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)
Date of Event	01/11/2024
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 compounding on 11jan2024 (lot #20240108-3f1d2b) one (1) bag as found to have a particle inside.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).A sample from batch j3l685 was received for evaluation.The set port had been accessed.The particle was placed in the fourier transform infrared spectroscopy (ftir) for analysis.The result was: bag1/particle1 - measured 1.05mm and was identified as rubber stopper.The reported defect was determined to be user mishandling of product and not a manufacturing defect.The material of the particle matches the rubber stopper, images of the inside and outside surfaces of the rubber stoper were obtained.The one spike was off center to the rubber stopper.There was no missing pieces to the inside surfae of the rubber stopper, but there was a missing piece from the outside surface of the rubber stopper.This concludes the stopper core was introduced into the pab empty bag by the customer when trying to access the bag during compounding.A review of our discrepancy management 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.Visual inspection on twenty (20) retained units showed no particulate matter was observed in any of the retained units.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
• 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: 18571459
• Report Number: 2021236-2024-00002
• Device Sequence Number: 20955316
• Product Code: KPE
• UDI-Device Identifier: 04046964187698
• UDI-Public: 04046964187698
• Combination Product (Y/N): N
• 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
• 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: 08/31/2025
• Device Catalogue Number: S5904-52
• Device Lot Number: J3L685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2024
• Supplement Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2023
• 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