Peripheral Catheter Insertion Kit F118081Recalls & reported problems
Bard Access Systems, Inc. · DOT PFlex, 18G 8cm Full · Class 2
All models of Peripheral Catheter Insertion Kit (54)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741110559), received between Mar 13, 2019 and Aug 12, 2021 — classified as 1 injury, 1 malfunction.
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Break1
- Material Frayed1
- Physical Resistance/Sticking1
- Retraction Problem1
Patient problems
- Foreign Body In Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 12, 2021Material Frayed; Material Frayed
IT WAS REPORTED "AFTER DEPLOYING CATHETER INTO VEIN, WIRE SHEARED AND REMAINED IN PATIENT. IT APPEARS WIRE UNRAVELED WHEN ATTEMPTING TO REMOVE. REMOVED WIRE FROM PATIENT. ADVISED RN/MD. OBTAINED XRAY OF ARM TO DETERMINE IF ANY WIRE REMAINED IN PATIENT."
Patient problems: Foreign Body In Patient
MAUDE report 12314116 ↗MalfunctionMar 13, 2019Break; Retraction Problem; Physical Resistance/Sticking
IT WAS REPORTED THAT GUIDEWIRE OF MIDLINE THREADED WITH NO RESISTANCE, BUT CATHETER ONLY THREADED HALFWAY BEFORE STOPPING ENTIRELY. THERE WAS NO ATTEMPT TO FORCE CATHETER FURTHER. WHEN ATTEMPTING TO WITHDRAWAL NEEDLE, THERE WAS RESISTANCE FELT. THE NEEDLE WOULD NOT RETRACT AT ALL. THE EXTERIOR CASE OF THE MIDLINE THEN SPLIT ALONG THE MIDDLE AND NEEDLE RETRACTED BUT GUIDEWIRE DID NOT. CATHETER WAS REMOVED AND FOUND TO BE DAMAGED WITH GUIDEWIRE STILL INSIDE CATHETER. ULTRASOUND WAS USED TO SEARCH FOR ANY SOLID/FOREIGN MATERIAL LEFT IN PATIENT'S ARM AND NONE WAS FOUND. A NEW MIDLINE CATHETER WAS SUCCESSFULLY PLACED WITH NO COMPLICATIONS AFTER MALFUNCTIONING MIDLINE WAS REMOVED. STERILE FIELD WAS NOT BROKEN DURING EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8417672 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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