MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. 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	10/30/2023
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 the user facility: during 100% black/white box visual inspection on (b)(6) 2023 pharmacist found one bag to have a white floating particle inside.Drug had been added to the bag.Per batch record instruction the mini spike is changed about every 20 spikes.We tested a few spikes into the stopper after compounding and did notice visible markings on the spike after withdrawal from the vial.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).A sample from batch j3k687 was received for evaluation.Based on the data from the investigation, the root cause of the reported particulate matter was not able to be determined at this time.The sample had been accessed/compromised, therefore this was determined not to be a manufacturing defect.The particle was placed in the fourier transform infrared spectroscopy (ftir) for analysis.The result was - particle 1 - measured 1.66mm and was identified as copolymer of styrene, acrylonitrile and butadiene.Based on the investigation, the particle did notoriginate from the b.Braun manufacturing process.A review of our discrepancy management system database found no related or similar discrepancies during the production of the batch.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.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.; 2525 mcgaw ave.; irvine CA 92614
• Manufacturer (Section G): B. BRAUN MEDICAL INC.; 2525 mcgaw ave.; irvine CA 92614
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 18150254
• Report Number: 2021236-2023-00001
• Device Sequence Number: 6747836
• Product Code: KPE
• UDI-Device Identifier: 04046964187698
• UDI-Public: 04046964187698
• 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): 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2023
• Supplement Date Received by Manufacturer: 11/01/2023
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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