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

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
Event or Problem Description
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.
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 inc.Internal report # (b)(4).The actual device involved in the reported incident was not returned for evaluation.Without the actual sample a thorough sample analysis could not be performed and no specific conclusions can be drawn.Photographs were submitted for review, a possible piece of particulate matter is visible; however, the identity or source of the particle were unable to be identified.The reported defect was unable to be confirmed.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or non-conformances of this nature.Visual inspection on twenty (20) retained units revealed that no leakage was observed in any of the retained units.The batch record was reviewed, and the batch met and passed all release criteria and tests.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or lot number.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: PAB®
• Common Device Name: CONTAINER, I.V. PRODUCT CODE: KPE
• Manufacturer (Section D): B. BRAUN MEDICAL INC - IRVINE; 2525 mcgraw ave; irvine CA 92614
• Manufacturer (Section G): B. BRAUN MEDICAL INC - IRVINE; 2525 mcgraw ave; irvine CA 92614
• Manufacturer Contact: jonathan severino ; 2525 mcgraw ave; irvine, CA 92614 ; 4847197289
• MDR Report Key: 18540087
• Report Number: 2021236-2024-00001
• Device Sequence Number: 15385442
• Product Code: KPE
• UDI-Device Identifier: 04046964187698
• UDI-Public: 04046964187698
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/08/2024

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: S5904-52
• Device Lot Number: J3K687
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2024
• Supplement Date Received by Manufacturer: 01/05/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2023
• 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