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

Model Number	471954
Medical Device Problem Code	Leak/Splash (1354)
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 the user facility: it was reported that the set cracked and leaked blood.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One used sample was provided for evaluation.The sample was visually evaluated, and it was noted there was a vertical crack on the green female l.L.Connector.The reported defect is not confirmed to be a manufacturing defect.Two extensive stress cracking tests were previously performed on house retain samples and no cracks or leakage was observed.All samples passed the tests performed.Incidents of cracked/leaking connectors can possibly be caused by several factors, including but not limited to the product being subjected to aggressive solvents/drugs, excessive mechanical stresses (over-tightening or frequent set manipulation), or other various unforeseen circumstances during the clinical application.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: EXTENSION 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 DOMINICIAN REPULIC 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: 15833426
• Report Number: 2523676-2022-00570
• Device Sequence Number: 12203163
• Product Code: FPA
• UDI-Device Identifier: 04022495770103
• UDI-Public: (01)04022495770103
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K153293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2023

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 Model Number: 471954
• Device Catalogue Number: 471954
• 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: 11/09/2022
• Supplement Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 11/21/2022
• Supplement Report FDA Received Date: 02/12/2023
• 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 Sex: Unknown