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

Catalog Number	S9504-52
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: a pab bag was observed with white particles in the bag.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) pab empty unit from j3k694/s5904-52 was received for evaluation.The unit was intact, and the ports had not been accessed.Through visual observation, foreign matter was observed.Optical images of the particles/defects were obtained, and their lengths were measured.The particles were extracted from the bags placed in the fourier transform infrared spectroscope for analysis.The results are shown below.- particle 1: measured 672um and was identified as polypropylene.The defect was inside the material of the pab bag.The defect was on the outside surface of the pab bag and would not have been in contact with the solution.- particle 2: measured 380um and was identified as polypropylene.The defect was fully embedded in the pab bag material and would not have been in contact with the solution.A review of our non-conformance system database found no related or similar discrepancies during the production of the batch.The batch record was reviewed, and the batch met and passed all release criteria and tests.Additionally, twenty (20) retain units were inspected by a certified inspector.Visual inspection of twenty (20) retain units performed by a certified inspector revealed no particulate matter.Based on the investigation results and available documentation, the possible source of particle 1 was due to machine, which was fixed.Human error also contributed as the 100% pm inspector may have not inspected 100% due to added tasks.A preventive action (retraining) was already performed to mitigate this incident.Regarding particle 2, the pab empty container (catalog no.S5904-52) uses a film material that is manufactured by third party vendor.A supplier corrective action request (scar) was issued to the vendor to investigate the embedded particle issue.Through the vendor investigation it was determined that the pm met the allowable particle size per specification.The embedded particle defect does not impact the function and integrity of the material provided to b.Braun.This type of defect was considered inherent to the manufacturing process of the film and is considered to be a cosmetic defect.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 CA 92614 5841
• Manufacturer (Section G): B. BRAUN MEDICAL INC - IRVINE; 2525 mcgraw ave; irvine CA 92614 5895
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197286
• MDR Report Key: 21619201
• Report Number: 2021236-2025-00007
• Device Sequence Number: 20938900
• Product Code: KPE
• UDI-Device Identifier: 04046964187698
• UDI-Public: (01)04046964187698(11)230826(17)250731(10)J3K694
• 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): 05/30/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2025
• Device Catalogue Number: S9504-52
• Device Lot Number: J3K694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2023
• 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