MAUDE Adverse Event Report: B. BRAUN MEDICAL INC - IRVINE PAB®; CONTAINER, I.V.

Catalog Number	S5904-52
Medical Device Problem Code	Infusion or Flow Problem (2964)
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: we recently started using the b.Braun pvc/dehp-free 150 ml bags to pool furosemide 10mg/ml for infusions.Since this change, the nurses observed that the bags had lots of tiny air bubbles which continuously set off the air in line alarm.The cassettes and lines were changed but the air in line alarm continued to go off.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report (b)(4).The actual device involved in the reported incident was not returned for evaluation.Without the actual sample a thorough sample analysis could not be performed and no specific conclusions can be drawn.A photograph was submitted for review.The image was visually inspected and revealed an empty pab mixing container containing liquid/solution with air bubbles inside.However, without a sample, a thorough investigation could not be performed and the exact root cause of the reported incident could not be determined.The batch record was reviewed, and the batch met and passed all release criteria and tests.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or lot number.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If additional pertinent information becomes available a follow-up report will be filed.

• 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 92614 5895
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197289
• MDR Report Key: 19014811
• Report Number: 2021236-2024-00005
• Device Sequence Number: 14409371
• Product Code: KPE
• UDI-Device Identifier: 04046964187698
• UDI-Public: 04046964187698
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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 Catalogue Number: S5904-52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2024
• 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): No
• 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