Midline Catheter Kit S4254108DRecalls & reported problems
Bard Access Systems, Inc. · 4Fr DL Provena Midline Max Barrier Kit · Class 2
All models of Midline Catheter Kit (31)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741154119), received between Apr 22, 2020 and Feb 26, 2025 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (5 reports).
1 FDA recall record name this device's identifier, 1 still open.
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.
Reports received per month
Recalls naming this device
- May 21, 2026Class IIOpen, Classified
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Z-2667-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak5
- Activation Problem2
- Contamination /Decontamination Problem1
Patient problems
- No Consequences Or Impact To Patient5
- No Clinical Signs, Symptoms or Conditions2
- Exposure to Body Fluids1
- Needle Stick/Puncture1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 26, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED BY THE CUSTOMER "I FOUND A LONG BLACK HAIR INSIDE A MIDLINE KIT UNDER THE GAUZE AND LIDOCAINE WHEN I OPENED FOR A CASE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21469055 ↗MalfunctionApr 19, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER THAT PATIENT IN THE ICU HAD A PROVENA 4F DL MIDLINE STARTED LEAKING WHERE THE CATHETER MEETS THE BIFURCATION. CONCERNS WERE THE RISK OF INFECTION AND INCOMPLETE DELIVERY OF MEDICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16773335 ↗MalfunctionJul 1, 2020Activation Problem; Activation Problem
IT WAS REPORTED THAT WHEN THE RN ENGAGED THE SAFETY MECHANISM ON THE INTRODUCER NEEDLE, AT FIRST IT LOOKED LIKE IT WORKED BUT WHEN THE RN PICKED IT BACK UP AND TILTED IT THE SAFETY MECHANISM SLID DOWN THE NEEDLE AND DID NOT ENGAGE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10217683 ↗MalfunctionJul 1, 2020Activation Problem; Activation Problem
IT WAS REPORTED THAT AFTER PLACING THE DOUBLE LUMEN MIDLINE, WHILE PICKING UP AND DISPOSING OF THE INTRODUCER NEEDLE INTO THE SHARPS BIN THE RN OBTAINED A CONTAMINATED NEEDLE STICK. THE SAFETY MECHANISM DID NOT FULLY ENGAGE.
Patient problems: Exposure to Body Fluids; Needle Stick/Puncture
MAUDE report 10217543 ↗MalfunctionApr 22, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED ¿APPEARED TO BE LEAKING FROM CATHETER¿. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9985591 ↗MalfunctionApr 22, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE MIDLINE CATHETER LEAKED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9985583 ↗MalfunctionApr 22, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE MIDLINE LEAKED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9985532 ↗MalfunctionApr 22, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE MIDLINE "LEAKED AROUND SITE WHEN FLUID BOLUS WAS GIVEN; DID NOT LEAK WHEN POWER FLUSHED WITH 20 CC¿S".
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9985529 ↗
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 · each recall links to the FDA recall notice
- 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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