MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. IV ADMINISTRATION SET; SET, ADMINISTRATION, INTRA

Catalog Number	V1921
Medical Device Problem Codes	Reflux within Device (1522); Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by user facility: brief inquiry description.Multiple events of secondary set backflowing into primary sets as reported in medwatch mw5156413: describe event or problem: our hospital is seeing device issues when using either the bbraun infusomat space pump iv set (ref (b)(4) ) or the bbraun secondary iv set (ref (b)(4) ).We are seeing the medications either backflow into the primary line or rapidly infuse.We believe that a check valve is not performing as intended incertain lots of these sets.For this event: iv tylenol hung on secondary infused in less than a minute.Attempted to hang iv zosyn (with same lot secondary tubing lot number) also started rapidly emptying.Both secondary tubing were bbraun ref v1921, lot 0061923959.Primary tubing ref (b)(4), lot 0061929620.Rehung same secondary tubing for zosyn with new primary tubing set and did not rapidly infuse.Ref report: mw5156412.
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.Please note: the medwatch received on 15jul2024 providing additional information for this specific event indicates that the secondary medication may have rapidly infused or free flowed.Based on the known issue of pump set backflow impacting bbmi infusion lines (2523676 - 5/23/24-002-c, res# (b)(4) ), it is likely an occurrence of backflow from the secondary medication bag to the primary bag was actually misinterpreted as free flow.However, additional information has not been received for this event at this time; and therefore, a medical device report for product problem is being submitted for free flow out of an abundance of caution.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).A review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.No sample was provided for evaluation.Due to the nature of the defect, it was noted that the secondary line cannot be attributed to causing the backflow found in the primary line.Further investigation revealed that the backflow exclusively occurred at the backcheck valve of the primary lines.Based on the data from the investigation, the root cause of the reported incident was unable to be determined.The reported defect was unable to be confirmed.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: IV ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown PA 18109
• Manufacturer (Section G): B. BRAUN DOMINICAN REPUBLIC INC.; las americas industrial park; km22 autopista las americas; santo domingo, ; DR
• Manufacturer Contact: jonathan severino ; 901 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 19976400
• Report Number: 2523676-2024-00705
• Device Sequence Number: 15568594
• Product Code: FPA
• UDI-Device Identifier: 04046964188558
• UDI-Public: (01)04046964188558
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K173361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2024

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: V1921
• Device Lot Number: 0061923959
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/16/2024
• 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 Age: 83 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian