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)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by user facility: during aql incoming inspection, one (1) empty bag was found to contain what appears to be two (2) string fibers.Pab 150 ml mixing container part #s5904-52 / expiry 1/2026 lot # j4b676 particle in bag = 1 bag.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).A sample from batch: j4b676 was received for evaluation.The ports were intact and had not been access.The particle was placed in the fourier transform infrared spectroscopy (ftir) for analysis.The result was: particle 1: measured 7.41mm and was identified as cellulose, cotton fiber.Based on the investigation, the particle identified as cotton fiber could have been introduced through the gowns used anywhere in the assembly and filling manufacturing process.This gap will be addressed through awareness retraining to the procedures.B.Braun has control processes in place for pm inspection.This includes pm aql during the assembly process and 100% inspection and aql during the packing process.100% pm inspections per load was performed for batch: j4b676 and the results passed aql inspection acceptance criteria.Laundry personnel were retrained to work instruction, "laundry room procedures" with emphasis on the section," staging and distribution of garments".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: 18941739
• Report Number: 2021236-2024-00003
• Device Sequence Number: 8204093
• 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): 05/03/2024

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: 01/31/2026
• Device Catalogue Number: S5904-52
• Device Lot Number: J4B676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2024
• 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