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: one (1) unannounced sample from batch j4b676, s5904-52 was received along with samples from manufacture complaint report (b)(4) for a report of particulate matter in the 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).One (1) sample from batch j4b676 was received for evaluation.The ports had been accessed and the sample drained.Visual inspection of the returned unit revealed a dark particulate matter.The particle was placed in the fourier transform infrared spectroscopy (ftir) for analysis.The result was: particle 1: measured 785 m, and was identified as adhesive, clay and other inorganic material.The eds spectrum showed the presence of carbon (c), oxygen (o), magnesium (mg), aluminum (al), silicon (si), sulphur (s), chlorine (cl), potassium (k), calcium (ca), titanium (ti), iron (fe) and copper (cu).Based on the investigation, the particle identified did not originate from the b.Braun manufacturing process.B.Braun has control processes in place for pm inspections.The container assembly process includes a pm aql inspection that occurs every 2 hours.The packing process includes a 100% pm inspection and a pm reject rate as well as a pm aql.Per the product batch records the reject rate and aqls were acceptable.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 5895
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197286
• MDR Report Key: 19014837
• Report Number: 2021236-2024-00006
• Device Sequence Number: 3880758
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2024

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: 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: 03/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 05/08/2024
• 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