MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. 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
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: during the visual inspection of lot 20260318-503e80, fentanyl citrate 2500 mcg/50 ml, one (1) bag was found to contain a foreign particulate.No injury reported.

• Brand Name: PAB ®
• Common Device Name: CONTAINER I.V.
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 861 marcon blvd.; allentown PA 18109
• Manufacturer (Section G): B. BRAUN MEDICAL INC - IRVINE; 2525 mcgraw ave; irvine CA 92614 5895
• Manufacturer Contact: elena reifenstein ; 861 marcon blvd.; allentown 18109 ; 8334251464
• MDR Report Key: 24799300
• Report Number: 2021236-2026-00004
• Device Sequence Number: 15839860
• Product Code: KPE
• UDI-Device Identifier: 04046964187698
• UDI-Public: (01)04046964187698(11)251112(17)271031(10)J5P444
• 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): 07/17/2026

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: J5P444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 07/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2025
• 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