PAB® S5904-52Recalls & reported problems
B. Braun Medical Inc. · Empty PAB® Partial Additive Bag, 150 mL · Class 2
Quick summary
This B. Braun PAB partial additive bag is a small empty IV bag used when compounding sterile drug solutions such as fentanyl drips. The 34 reports mostly describe contamination found during visual inspection — dark, grey or black specks, particles, or spots inside the bag — along with a few bags leaking while being filled, cracks or deformed ports, and material that had degraded. No deaths or injuries were reported, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 34
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 04046964187698), received between Mar 19, 2020 and May 1, 2026 — classified as 34 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (31 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Contamination /Decontamination Problem31
- Fluid/Blood Leak3
- Degraded2
- Infusion or Flow Problem1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions33
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 1, 2026Fluid/Blood Leak; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: DURING COMPOUNDING OF LOT 20260406-0F9689, FENTANYL CITRATE 2500 MCG/50 ML, FIVE (5) BAGS WERE FOUND TO BE LEAKING UPON BEING FILLED WITH PRODUCT. DURING THE VISUAL INSPECTION, ONE (1) BAG WAS FOUND TO CONTAIN A FOREIGN PARTICULATE. NO INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25055549 ↗MalfunctionApr 7, 2026Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: DURING THE VISUAL INSPECTION OF LOT 20260318-503E80, FENTANYL CITRATE 2500 MCG/50 ML, ONE (1) BAG WAS FOUND TO CONTAIN A FOREIGN PARTICULATE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24799300 ↗MalfunctionFeb 20, 2026Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: DURING THE VISUAL INSPECTION OF LOT # 20260130-0119D8 FENTANYL DRIPS, ONE (1) BAG WAS DISCOVERED TO HAVE A DARK/ROUND PARTICULATE. THE UNIT IS AVAILABLE FOR EVALUATION. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24400031 ↗MalfunctionJan 21, 2026Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: DURING THE VISUAL INSPECTION OF LOT J5J457, FENTANYL CITRATE 2500 MCG/50 ML, ONE (1) 150ML PAB BAG WAS DISCOVERED TO HAVE A GREY-COLORED PARTICULATE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24131402 ↗MalfunctionJan 13, 2026Degraded; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: DURING COMPOUNDING OF LOT 20251212-21379A, PRIOR TO THE ADDITION OF ACTIVE PHARMACEUTICAL INGREDIANT (API), ONE (1) 150ML PAB BAG WAS DICOVERED WITH A DEFORMED PORT. DURING VISUAL INSPECTION, TWO (2) PAB BAGS WERE NOTED WITH DEFECTS; ONE (1) CONTAINING A BLACK SPOT INSIDE THE BAG AND ANOTHER WITH A CRACK NEAR THE PORT AREA. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24056633 ↗MalfunctionSep 18, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: ACCORDING TO THE COMPLAINANT, DURING COMPOUNDING OF LOT #20250819-4F09CE, SEVERAL BAGS WERE FOUND TO HAVE WHAT APPEARS TO BE EMBEDDED WHITE SPOTS. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23084102 ↗MalfunctionMar 17, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: ONE (1) BAG WAS OBSERVED WITH A FOREIGN PARTICULATE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21619203 ↗MalfunctionMar 17, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: A WHITE UNKNOWN PARTICLE WAS OBSERVED IN THE BAG. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21619202 ↗MalfunctionMar 17, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: A PAB BAG WAS OBSERVED WITH WHITE PARTICLES IN THE BAG. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21619201 ↗MalfunctionMar 12, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: DURING 100% INSPECTION OF TEH UNIT , ONE (1) BAG WAS FOUND TO HAVE FOREIGN PARTICULATE MATTER. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21582977 ↗MalfunctionFeb 19, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: THE COMPLAINANT REPORTED THAT DURING 100% VISUAL INSPECTION, A PARTICLE WAS OBSERVED IN ONE (1) BAG. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21415316 ↗MalfunctionFeb 18, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: DURING 100% VISUAL INSPECTION OF COMPUNDED LOT, ONE (1) BAG WAS FOUND WITH PARTICULATE MATTER. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21395741 ↗MalfunctionFeb 6, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: DURING 100% VISUAL INSPECTION OF COMPOUNDED LOT # J4N717, TWO (2) BAGS WERE FOUND WITH ONE (1) FOREIGN PARTICULATE IN EACH. NO INJUSRY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21324409 ↗MalfunctionJan 17, 2025Fluid/Blood Leak; Contamination /Decontamination Problem; Fluid/Blood Leak; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: DURING COMPOUNDING, ONE (1) UNIT WAS FOUND WITH A FOREIGN PARTICULATE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21178853 ↗MalfunctionApr 1, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: ONE (1) UNANNOUNCED SAMPLE FROM BATCH J4B676, S5904-52 WAS RECEIVED ALONG WITH SAMPLES FROM MANUFACTURE COMPLAINT REPORT (B)(4) FOR A REPORT OF PARTICULATE MATTER IN THE BAG. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19014837 ↗MalfunctionApr 1, 2024Infusion or Flow Problem; Infusion or Flow Problem
AS REPORTED BY USER FACILITY: WE RECENTLY STARTED USING THE B.BRAUN PVC/DEHP-FREE 150 ML BAGS TO POOL FUROSEMIDE 10MG/ML FOR INFUSIONS. SINCE THIS CHANGE, THE NURSES OBSERVED THAT THE BAGS HAD LOTS OF TINY AIR BUBBLES WHICH CONTINUOUSLY SET OFF THE AIR IN LINE ALARM. THE CASSETTES AND LINES WERE CHANGED BUT THE AIR IN LINE ALARM CONTINUED TO GO OFF. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19014811 ↗MalfunctionMar 20, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: DURING 100% INPROCESS INSPECTION, TWO (2) BAGS WERE FOUND TO CONTAIN ONE (1) SMALL PARTICULATE EACH. LOT # J3S705 PARTICLE IN BAG = 1 BAG. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18942523 ↗MalfunctionMar 20, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: DURING AQL INCOMING INSPECTION, ONE (1) EMPTY BAG WAS FOUND TO CONTAIN WHAT APPEARS TO BE TWO (2) STRING FIBERS. PAB 150 ML MIXING CONTAINER PART #S5904-52 / EXPIRY 1/2026 LOT # J4B676 PARTICLE IN BAG = 1 BAG. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18941739 ↗MalfunctionJan 24, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: DURING COMPOUNDING ON 11JAN2024 (LOT #20240108-3F1D2B) ONE (1) BAG AS FOUND TO HAVE A PARTICLE INSIDE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18571459 ↗MalfunctionJan 18, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: THERE IS A QUALITY CONCERN WITH THE 150 ML BRAUN PAB MIXING CONTAINER REF (B)(4). LOT J3K687 EXP 07/25. A 1CM PIECE OF PLASTIC, FLOATING INSIDE THE BAG, WAS IDENTIFIED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18540087 ↗MalfunctionNov 16, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: DURING 100% BLACK/WHITE BOX VISUAL INSPECTION ON (B)(6) 2023 PHARMACIST FOUND ONE BAG TO HAVE A WHITE FLOATING PARTICLE INSIDE. DRUG HAD BEEN ADDED TO THE BAG. PER BATCH RECORD INSTRUCTION THE MINI SPIKE IS CHANGED ABOUT EVERY 20 SPIKES. WE TESTED A FEW SPIKES INTO THE STOPPER AFTER COMPOUNDING AND DID NOTICE VISIBLE MARKINGS ON THE SPIKE AFTER WITHDRAWAL FROM THE VIAL. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18150254 ↗MalfunctionNov 15, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: AFTER COMPOUNDING FENTANYL INTO THE PAB BAG A DARK COLORED PARTICLE WAS FOUND IN THE SOLUTION. NO INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12810914 ↗MalfunctionJul 13, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 1: DURING THE IN-PROCESS VISUAL INSPECTION FENTANYL DRIP BAGS WERE FOUND TO HAVE A DARK COLORED FLOATING PARTICLE INSIDE THE COMPOUNDED BAG. DRUG PRODUCT HAD BEEN ADDED TO THE BAG. NO INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12157931 ↗MalfunctionJul 13, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 7: DURING THE IN-PROCESS VISUAL INSPECTION FENTANYL DRIP BAGS WERE FOUND TO HAVE A DARK COLORED FLOATING PARTICLE INSIDE THE COMPOUNDED BAG. DRUG PRODUCT HAD BEEN ADDED TO THE BAG. NO INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12157930 ↗MalfunctionJul 13, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 4: DURING THE IN-PROCESS VISUAL INSPECTION FENTANYL DRIP BAGS WERE FOUND TO HAVE A DARK COLORED FLOATING PARTICLE INSIDE THE COMPOUNDED BAG. DRUG PRODUCT HAD BEEN ADDED TO THE BAG. NO INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12157929 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.