Midline Catheter Kit PP4154108DGPRecalls & reported problems
Bard Access Systems, Inc. · DOT 4FSL PWERML MBP W/GIVA W/PC · Class 2
All models of Midline Catheter Kit (31)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741185175), received between Mar 7, 2022 and Mar 13, 2026 — classified as 1 injury, 5 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (5 reports).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak5
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Foreign Body In Patient1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryMar 13, 2026Material Deformation
IT WAS REPORTED THAT TWO VASCULAR ACCESS TEAM MEMBERS WERE PLACING A LINE ON A PATIENT. THE FIRST HAD MET RESISTANCE AFTER ADVANCING THE CATHETER 10CM. THE OTHER VASCULAR ACCESS TEAM MEMBER TOOK OVER THE PLACEMENT. THEY WERE ABLE TO MOVE PAST THE RESISTANCE BUT WOULD AT TIMES MEET RESISTANCE BUT WOULD BE ABLE TO CONTINUE ADVANCE. EVENTUALLY THE 2ND TEAM MEMBER COULD NOT ADVANCE ANY FURTHER, THEY TRIED PULLING THE CATHETER BUT IT WOULD NOT MOVE IN EITHER DIRECTION. THEY REQUESTED ADDITIONAL MEMBERS TO COME ASSESS THE PATIENT. THEY TOOK THE PATIENT TO INTERVENTIONAL RADIOLOGY TO SEEK ADDITIONAL ASSISTANCE. THE CATHETER WAS INTERTWINED INTO A BALL IN THE SUBCUTANEOUS TISSUE. THE CATHETER HAD TO BE SURGICALLY REMOVED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 24591498 ↗MalfunctionMar 10, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED "TRIMMABLE MIDLINE LEAKING AT THE SITE TWICE." NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13726084 ↗MalfunctionMar 10, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED LEAKING MIDLINE. ADDITIONAL INFORMATION RECEIVED 02/18/2022: A DETAILED DESCRIPTION OF THE EVENT: TRIMMABLE MIDLINE LEAKING AT THE SITE. WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED? STAT-LOCK. WAS THE PRODUCT USED ON A PATIENT? YES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13721602 ↗MalfunctionMar 10, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED "TRIMMABLE MIDLINE LEAKING AT THE SITE." NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13721599 ↗MalfunctionMar 10, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED "TRIMMABLE MIDLINE LEAKING TWICE AT THE SITE." NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13721576 ↗MalfunctionMar 7, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED A LEAKING MIDLINE. ADD INFO RCVD 02/18/2022: DESCRIPTION: TRIMMABLE MIDLINE LEAKING AT THE SITE WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED? STAT-LOCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13685076 ↗
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 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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