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	01/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: during 100% visual inspection of compounded lot # j4n717, two (2) bags were found with one (1) foreign particulate in each.No injusry 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).Five (5) pab units from lot j4n717/s5904-52 were received for evaluation.The units were empty, the add port caps were removed, and the ports had been accessed.Through visual observation, particulate matter (pm) was observed in the units.All of the samples were sent to photometrics for further analysis and identification.Optical images of the particles were taken, and its lengths were measured.Additionally, the particles were placed in the fourier transform infrared spectroscope (ftir) and/or in the scanning electron microscope (sem) for energy dispersive x-ray spectroscopy (eds) analysis.The results are shown below.Pab unit #1 particle 1- measured 4.04 mm and was identified as cellulose (cotton fiber) and inorganic material.The eds spectrum shows the presence of carbon (c), oxygen (o), silicon (si), sulphur (s), potassium (k) and calcium (ca).The particle was on the outside of the pab unit and would not have been in contact with the solution.Pab unit #2 particle 1- measured 182um and was identified as cellulose (cotton fiber) and inorganic material.The eds spectrum shows the presence of carbon (c), oxygen (o), sodium (na), silicon (si), sulphur (s), chlorine (cl), potassium (k) and calcium (ca).The particle was on the inside of the pab unit and would have been in contact with the solution.Pab unit #3 particle 1: measured 1.59mm and was identified as polypropylene.The particle was on the inside of the pab unit and would have been in contact with the solution.Pab unit #4 particle 1- measured 542um and was identified as benzoic acid and inorganic material.The eds spectrum shows the presence of carbon (c), oxygen (o) and zinc (zu).The particle was embedded the bag material of the pab unit and would not have been in contact with the solution.Pab unit #5 particle 1- measured 587um and was identified as benzoic acid and inorganic material.The eds spectrum shows the presence of carbon (c), oxygen (o), and zinc (zn).The particle was embedded in the bag material of the pab unit and would not have been in contact with 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.Additionally, visual inspection of twenty (20) retain units performed by a certified inspector revealed that no particulate matter based on the results of the investigation, the possible source of the observed pm in units #1 and #2 was equipment used in manufacturing.Human error also contributed to the observed pm as the 100% pm inspector may have not inspected the units thoroughly due to added tasks.A preventative action (retraining) was performed in order to mitigate this incident.Regarding the remaining units, the containers use film material that is manufactured by a third-party vendor.As a result, a supplier corrective action request (scar) was issued to the vendor in order to investigate the embedded particle issue.Vendor investigation determined that the size of the particles was acceptable and conformed to specifications.Additionally, it was determined that the embedded particle defect did not impact the function and integrity of the material provided to b.Braun.This type of defect is considered inherent to the manufacturing process of the film and is considered to be a cosmetic defect.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: 21324409
• Report Number: 2021236-2025-00002
• Device Sequence Number: 15433212
• Product Code: KPE
• UDI-Device Identifier: 04046964187698
• UDI-Public: (01)04046964187698(11)241021(17)260930(10)J4N717
• 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 Expiration Date: 09/30/2026
• Device Catalogue Number: S5904-52
• Device Lot Number: J4N717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2024
• 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