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

Model Number	352901
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Chemical Exposure (2570)
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: event 4: it was reported that chemotherapy leaked at the connection port during use.No injury reported.It should be noted that two other potential lots were provided.Lot number 0061734545; expiry date 04/30/2023; production date 05/27/2020.Lot number 0061722066; expiry date 02/28/2023; production date 03/03/2020.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number(b)(4).Three (3) photos depicting multiple angles of the valve were provided for evaluation.Upon further inspection of the photos, no defects were present on the valve.Retained units from the reported potential lots were inspected and found to be within specification.In addition, a review of the discrepancy management system (dsms) database performed for the reported potential lot numbers revealed no abnormalities or non-conformances noted during in process or final product inspection.Based on the data from our investigation, the exact root cause of the reported defect could not be determined at this time.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If a sample and/or any additional pertinent information becomes available, a follow-up will be submitted.

• Brand Name: SAFEDAY
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown, pa
• MDR Report Key: 10451368
• Report Number: 2523676-2020-00242
• Device Sequence Number: 3524681
• Product Code: FPA
• UDI-Device Identifier: 04046964293771
• UDI-Public: 04046964293771
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K955585
• 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 faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2020

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 Expiration Date: 10/31/2022
• Device Model Number: 352901
• Device Catalogue Number: 352901
• Device Lot Number: 0061710632
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 09/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1