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	02/11/2025
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: one (1) bag was observed with a foreign particulate.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) pab empty unit from lotj4s670/s5904-52 was received for evaluation.The unit was intact, and the ports had not been accessed.Through visual observation, black particulate matter (pm was observed on the right-bottom side of the received unit.Optical images of the particle/defect were obtained, and the length was measured.Furthermore, the particle was extracted from the bags placed in the fourier transform infrared spectroscope (ftir) for analysis.The results are shown below.- particle 1: measured 539um and was identified as proteins and sugars (milk).The particle was on the inside of the bag, not embedded, and would have been in contact with the solution.A review of our non-conformance system database found no related or similar discrepancies during the production of the batch.The batch record was also reviewed, and the batch met and passed all release criteria and tests.Twenty (20) retain units were visually inspected by a certified pm inspector, and one (1) unit was observed with foreign particulate.The pab empty container uses a film material manufactured by a third-party vendor.A supplier corrective action request (scar) was issued to the vendor to investigate the particle issue.Through the vendor investigation, it was determined that there was cross contamination due to insufficient flushing of the solution delivery line.Based on the investigation conducted in the pab filling lines 2 and 4 - areas that used to manufacture empty container catalog no.S5904-52 batch j4s670, pab empty containers are delivered from pab assembly and are then rinsed with distilled water.Distilled water is then sprayed onto ports of the containers, and the med port (or nonaccess port) caps are crimped onto the container.There were no significant incidents identified during the review of records that may have contributed to the observed particle from the returned sample.Therefore, the root cause of the reported incident is unable to be determined at this time.There is a 100% in-process inspection conducted after the sterilization process.In addition, there are also in-process visual inspection conducted for batch j4s670.These inspections were all found to be acceptable, and the batch was released on its own merit.Based on the results of the investigation, this is considered to be an isolated incident.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 5895
• 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: 21619203
• Report Number: 2021236-2025-00008
• Device Sequence Number: 8425662
• Product Code: KPE
• UDI-Device Identifier: 04046964187698
• UDI-Public: (01)04046964187698(11)241205(17)261130(10)J4S670
• 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): 05/30/2025

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 Catalogue Number: S5904-52
• Device Lot Number: J4S670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2024
• 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