FDA issues early alert over black matter in IV lines
The U.S. Food and Drug Administration (FDA) said it’s aware of an issue with IV tubes, where black matter has been found within the walls of the plastic walls, signaling a contamination issue.
ICU Medical said samples containing the particulates are being returned for analysis to help identify the problem. Until then, the devices are being removed from use and distribution.
Typically sterile, these tubes are used to connect medication and fluid bags to patients, as administered through an IV line.
ICU Medical and the FDA said in an announcement this could be a potentially high-risk issue, though there was no mention of patient injuries. The FDA described the notice as an early alert regarding a potential safety issue.
Next steps
For now, the FDA is asking all clinicians using ICU Medical IV tubing to examine it for any signs of contamination.
Any signs of anomalies should be reported to the MedWatch program for investigation. That can be done by clicking here.
A letter was issued to known customers on May 15, where ICU Medical recommended all users look for black specs within IV lines, in addition to the drip chamber. Any condensation should be examined for signs of particulates.
Any anomalies should be reported to the FDA MedWatch program. The agency is looking to identify the unique identification numbers (UDIs) associated with potentially defective products.
If black matter is noticed anywhere in the IV, cease use on patients immediately and quarantine devices. Users are advised to contact ICU Medical immediately to help with the investigation.
ICU Medical can be contacted at [email protected] or online at ICU Medical complaint portal
At this time, neither ICU Medical nor the FDA have identified evidence indicating that the reported condition represents a risk of biological contamination; however, this has not been ruled out.
The initial report came from one healthcare facility, ICU Medical confirmed.
For more, read the full FDA alert by clicking here.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.