Peripheral Catheter Insertion Kit F220081Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741110672), received between Dec 16, 2016 and Aug 16, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Crack” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 16, 2018Crack; Retraction Problem; Self-Activation or Keying; Reset Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT MIDLINE WAS ATTEMPTED TO BE PLACED IN PATIENT'S LEFT UPPER ARM CEPHALIC VEIN. IT WAS STATED, "UPON ENTERING MIDLINE, GUIDEWIRE WAS ADVANCED AND STARTED TO POP UP SUPERIORLY TO INSERTION SITE UNDER THE SKIN. GUIDE WIRE WAS THEN RETRACTED TO ABORT PLACEMENT HOWEVER UPON RETRACTING A CRACK WAS HEARD. GUIDE WIRE WAS DIFFICULT TO RETRACT AT THIS POINT AS WELL AS CATHETER DIFFICULT TO RETRACT WITHOUT RESISTANCE BEING MET. UPON US GUIDANCE, NEEDLE AND CATHETER STILL IN TISSUE AND CATHETER IN VEIN. INTERVENTIONAL RADIOLOGY CALLED TO BEDSIDE. TO THEIR DISCRETION, NEEDLE TIP WAS NOT IN VEIN HOWEVER CATHETER WAS IN VEIN. IR MD WAS CALLED TO BEDSIDE AND TOOK OUT MIDLINE WHICH ONCE PULLED SHOWED NEEDLE HAD PUNCTURED THROUGH CATHETER AND GUIDE WIRE WAS TORTIOUS. TIP OF GUIDE WIRE ACTUALLY FELL APART FROM MAIN GUIDE WIRE WHILE OUT OF PATIENT'S ARM. PATIENT HAD XRAY OF ARM TO EVALUATE IF ANY OTHER FOREIGN BODY IN PLACE. XRAY CONFIRMED NO FOREIGN BODY. PT SUSTAINED SMALL HEMATOMA THAT RESOLVED ON ITS OWN".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7791636 ↗
• InjuryDec 16, 2016Positioning Failure; Material Fragmentation

  IT WAS REPORTED BY BAS CLINICAL SPECIALIST THAT SHE WAS AT THE FACILITY TRAINING WHEN THE ALLEGED FAILURE OCCURRED. WHILE INSERTING THE POWERGLIDE INTO THE LEFT BRACHIAL VEIN, THE GUIDEWIRE WAS INSERTED, THE CATHETER WAS DEPLOYED, AND WHEN THE HOUSING UNIT WAS REMOVED IT WAS REPORTED THAT THE GUIDEWIRE WAS SHEARED. CLINICAL SPECIALIST STATED THAT THE NEEDLE RETRACTED INTO THE SAFETY DEVICE AND THE CATHETER WAS THEN REMOVED. IT WAS FOUND UNDER X-RAY AND ULTRASOUND THAT A PIECE OF THE GUIDEWIRE REMAINED IN THE PATIENT. PATIENT WAS SENT TO INTERVENTIONAL RADIOLOGY FOR REMOVAL.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6183552 ↗