Midline Catheter Kit PP4154108DGPXRecalls & reported problems
Bard Access Systems, Inc. · DOT 4FSL PWERML MBP W/GIVA PC NG · Class 2
All models of Midline Catheter Kit (31)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741185199), received between Jun 3, 2021 and Jun 3, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Defective Component” (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
- Defective Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 3, 2021Defective Component; Defective Component
IT WAS REPORTED "I WAS PLACING A ML AND AFTER CANNULATING THE VEIN WITH THE STYLUS NEEDLE AND GETTING BLOOD RETURN, THE GUIDEWIRE WOULD NOT PASS THRU THE HUB OF THE STYLUS. I HAD TO ABORT AND STICK THE PATIENT A SECOND TIME WITH THE ANGIOCATH IN THE KIT. THE WIRE PASSED WITHOUT INCIDENT AND THE LINE WAS PLACED SUCCESSFULLY. AFTER THE PROCEDURE I WENT BACK TO THE STYLUS AND TRIED SEVERAL THINGS TRYING TO THREAD THE WIRE THRU IT. I BELIEVE THERE WAS A BURR OR LIP OF METAL AT THE HUB THAT OBSTRUCTED THE PASSAGE OF THE WIRE.¿ IT WAS REPORTED THE DEVICE WAS DISCARDED. ADD INFO RCVD 05/11/2021: DATE OF OCCURRENCE: 05/07/2021 PLACEMENT INFO: N/A. WAS THERE PATIENT HARM REPORTED?: NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11931556 ↗
Other Midline catheter devices
- Midline Catheter Kit P4154108DBard Access Systems, Inc. · Midline catheter1 recall1 death126 reports
- ARROW IPN921959Teleflex Incorporated · Midline catheter2 recalls0 reports
- Midline Catheter Kit S4153108BDPBard Access Systems, Inc. · Midline catheter1 recall36 reports
- Midline Catheter Kit S4153108DBard Access Systems, Inc. · Midline catheter1 recall32 reports
- Midline Catheter Kit S4153108DGPBard Access Systems, Inc. · Midline catheter1 recall15 reports
- Midline Catheter Kit S4254108BDPBard Access Systems, Inc. · Midline catheter1 recall11 reports
- Midline Catheter Kit P4154108Bard Access Systems, Inc. · Midline catheter1 recall10 reports
- ARROW IPN037698Teleflex Incorporated · Midline catheter1 recall9 reports
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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