Alaris 11608375Recalls & reported problems
BD Switzerland Sàrl · Extension Set, 53 cm (21 in) · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885403273971), received between May 31, 2019 and May 31, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break1
- Failure to Disconnect1
- Physical Resistance/Sticking1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 31, 2019Break; Failure to Disconnect; Physical Resistance/Sticking; Break; Failure to Disconnect; Physical Resistance/Sticking
IT WAS REPORTED THAT DURING A DRESSING AND TUBING CHANGE FOR A HOMECARE PATIENT, THE NURSE ATTEMPTED TO REMOVE THE TUBING FROM THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LUMEN HUB. THE TUBING WAS STUCK, AND IN THE PROCESS OF UNTWISTED THE DEVICE, THE TUBING SNAPPED, LEAVING A PIECE OF THE PLASTIC MALE END OF THE EXTENSION TUBING INSIDE THE PICC HUB. THE NURSE WAS NOT ABLE TO REMOVE THE PIECE OF TUBING IN THE HUB RESULTING IN A PICC LINE REPLACEMENT. THERE WAS NO PATIENT HARM AS A RESULT OF THE EVENT OR THE PICC LINE REPLACEMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8661071 ↗
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.