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

Model Number	472060
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The device involved has not been received for evaluation and 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 it appears that movement from the patient causes the connection to loosen, allowing blood, fluids, and meds to run freely out onto the floor and anyone near.The part of the set that screw into the luer lock safesite cap, is checked at least twice, if not more, for tightness.The patient had hep c.No harm came to the patient in this case, however, their blood spewed out onto one of the nurses.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Three (3) samples were returned for evaluation.Visual examination of the samples was unable to note any defects.The luer fitting of the items were tested using iso luer gages, no nonconformities were observed.The sample was then leak tested per specification with passing results.The reported defect was not confirmed.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.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: SAFSITE®
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown, pa
• MDR Report Key: 9817490
• Report Number: 2523676-2020-00077
• Device Sequence Number: 16498316
• Product Code: FPA
• UDI-Device Identifier: 04046964184697
• UDI-Public: 04046964184697
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K942988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2020

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: 08/31/2024
• Device Model Number: 472060
• Device Catalogue Number: 472060
• Device Lot Number: 0061698761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2020
• Initial Date Received by Manufacturer: 03/05/2020
• Supplement Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 04/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1