MAUDE Adverse Event Report: B. BRAUN MEDICAL INC - IRVINE PAB ®; CONTAINER I.V.

Catalog Number	S5904-52
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
Event or Problem Description
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.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Returned materials included a yellow loop and one (1) accessed/compromised pab sample with the lot number and add port cut off.It appeared that the bag was cut to remove the particle, which was returned inside packaging labeled "fisherbrand disposable inoculating loops/needles." the add port showed evidence of an off-target puncture.The needle appeared to have struck the aluminum cap, and the interior surface of the port plastic also showed signs of damage consistent with a mis puncture.An optical image of the particle was obtained, and its length was measured.The particle was then placed in the fourier transform infrared spectroscope (ftir) for analysis.Optical images of the exterior and interior of the add port stopper were then obtained.The length of the puncture hole on both sides of the stopper was measured, and the size and material of the stopper was consistent with it coming from the add port stopper.The results of this analysis are shown below.Pab bag particle 1: the particle measured 1.19 mm and was identified as being a part of the gray rubber stopper.A review of our non-conformance system database found no related or similar discrepancies during the production of the batch.The batch record was also reviewed, and the batch met and passed all release criteria and tests.Additionally, twenty (20) retain units were inspected by a certified particulate matter (pm) inspector, and no gray pm was observed.Based on the evaluation performed, the grey particulate recovered from the returned pab bag was identified as a fragment of the add port rubber stopper.Examination of the returned components revealed evidence of an off-target needle puncture, including impact marks on the aluminum cap and damage to the interior and exterior surfaces of the port consistent with a mis-puncture event.No manufacturing defects were observed in the bag material or port assembly.In addition, the b.Braun sustaining team replicated the reported condition.Testing demonstrated that repeated puncturing of a stopper with the same needle can generate rubber fragments consistent with those observed in the returned sample.While only a single access was reported, internal testing showed that stopper degradation becomes more pronounced after approximately four (4) punctures.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: PAB ®
• Common Device Name: CONTAINER I.V.
• Manufacturer (Section D): B. BRAUN MEDICAL INC - IRVINE; 2525 mcgraw ave; irvine 92614
• Manufacturer (Section G): B. BRAUN MEDICAL INC - IRVINE; 2525 mcgraw ave; irvine CA 92614 5895
• Manufacturer Contact: elena reifenstein ; 861 marcon blvd.; allentown, PA 18109 ; 4847197286
• MDR Report Key: 24131402
• Report Number: 2021236-2026-00002
• Device Sequence Number: 12114235
• Product Code: KPE
• UDI-Device Identifier: 04046964187698
• UDI-Public: (01)04046964187698(11)250721(17)270630(10)J5J457
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K840388
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: S5904-52
• Device Lot Number: J5J457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown