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

Catalog Number	S5904-52
Medical Device Problem Codes	Fluid/Blood Leak (1250); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by user facility: during compounding, one (1) unit was found with a foreign particulate.No injury reported.
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.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Two (2) accessed samples with attached foil-peel tabs at the set ports were received for evaluation.One (1) sample was observed to have leakage at the top cap while the other sample was observed to have particulate matter (pm), the latter likely the result of coring.Subject matter expert (sme) evaluation revealed that the puncture was not at the center, and the aluminum cap was damaged, likely due to handling.The add port rubber stopper was removed and examined, and it had a piece missing on the interior that was of similar size and shape (1.61 mm x 0.44 mm) as the particle.Therefore, it can be concluded that the particle was the missing piece of the add port rubber stopper.An optical image of the particle was obtained, and the particle was placed in the fourier transform infrared spectrometer (ftir) for analysis.The results are shown below: - particle 1: measured 1.74 mm x 0.72 mm and was identified as chlorobutyl rubber.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) retains were inspected by a pm inspector, and no pm was observed.No defects were detected on any of the retained units.Regarding the sample with pm, it appeared that a blunted needle (punctured more than one time) was used to puncture the stopper which, in turn, caused coring.Based on the sample evaluation, it was concluded that the particle was most likely introduced into the pab empty bag while trying to access the bag during compounding.Therefore, the reported defect is not confirmed to be manufacturing related.It is recommended that a new needle be used with each pab bag for single use during admixing to minimize coring of the stopper.Any container which is suspect should not be used.This information is found in the direction for use (dfu) under directions for use of pab® mixing container.Regarding the leaking sample, the batch was observed to have met all acceptance quality limit (aql) and final batch release criteria.It was determined that the leakage was likely caused by a third party and, therefore, is not confirmed to be manufacturing related.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 5895
• 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: 21178853
• Report Number: 2021236-2025-00001
• Device Sequence Number: 19908689
• Product Code: KPE
• UDI-Device Identifier: 04046964187698
• UDI-Public: (01)04046964187698(11)240210(17)260131(10)J4B676
• 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): 04/30/2025

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: 01/31/2026
• Device Catalogue Number: S5904-52
• Device Lot Number: J4B676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2024
• Is the Device Labeled for Single Use? (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