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

Catalog Number	V1921
Medical Device Problem Codes	Leak/Splash (1354); Free or Unrestricted Flow (2945)
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, administering (b)(4) unit prbc to patient when tubing started leaking at the disc above the y port.It was unable to be tightened or adjusted.Delay in treatment as a result.Our hospital is seeing device issues when using either the b.Braun infusomat space pump iv set (b)(4) or the bbraun secondary iv set (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 in certain lots of these sets.Ref reports: mw5156432, mw5156433.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One sample was provided for evaluation.Upon visual inspection of the returned sample, no deviations were noted.The sample was connected to a bag and fluid was pushed through the set.An attempt was made to engage the roller clamp and it restricted flow as intended.The sample was leak tested per specification with no leakages identified.Due to the nature of the reported issue, it should be noted that the secondary line cannot be attributed to causing backflow found in the primary line.Based on the data from the investigation, the reported defect was unable to be confirmed.Five retains from the reported lot number were tested per specification and passed.A review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformance's were noted during the in process or final product inspection.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, INTRAVASCULAR
• 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; km 22 autopista las americas; santo domingo, ; DR
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 20407669
• Report Number: 2523676-2024-00734
• Device Sequence Number: 3579429
• 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): 01/24/2025

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 Catalogue Number: V1921
• 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: 07/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 69 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White