MAUDE Adverse Event Report: B. BRAUN MEDICAL INC PAB®; CONTAINER, IV

Model 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	11/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: after compounding fentanyl into the pab bag a dark colored particle was found in the solution.No injuries were reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).The device involved has not been received for evaluation and 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 inc.Internal report number (b)(4).One (1) empty pab unit was received from batch j1e651 for evaluation.A black particulate matter was observed inside the unit.A single puncture was observed in the underside of the stopper.There was no visible evidence of stopper material missing (coring) due to needle insertion at the entry or exit point of the stopper.The particle inside the empty pab bag was identified as butyl rubber which is the material in rubber stoppers.Since the material the pab stopper is the most common material sold in the us for drug vials, it is possible the pm particle came from another source of coring (stopper) that was injected into the empty pab bag through the lumen of the needle when medication was added.Investigation shows the source of the core is not the pab container (stopper) returned.Typically, there would be evidence such as missing material or fragment in the top or bottom side of the stopper if the core were from the returned sample.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 particulate matter was observed in any of the retained units.

• Brand Name: PAB®
• Common Device Name: CONTAINER, IV
• Manufacturer (Section D): B. BRAUN MEDICAL INC; 2525 mcgaw avenue; irvine CA 92614 5895
• Manufacturer (Section G): B. BRAUN MEDICAL INC; 2525 mcgaw avenue; irvine CA 92614 5895
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 12810914
• Report Number: 2021236-2021-00012
• Device Sequence Number: 5575158
• Product Code: KPE
• UDI-Device Identifier: 04046964187698
• UDI-Public: (01)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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2022

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: 05/31/2023
• Device Model Number: S5904-52
• Device Catalogue Number: S5904-52
• Device Lot Number: J1E651
• 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: 11/03/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown