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

Model Number	470195
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Chemical Exposure (2570); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/20/2020
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 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: customer reports two (2) chemotherapy incidents.Event 1: it was reported that during chemotherapy of busulfan, the product leaked.The lower y-site leaked.Chemo leaked on patients arm, shirt and bed.No injury reported.Event 2, will be reported via mfr report number: 2523676-2020-00081 for the second event, it was reported that the nurse noted that the product was leaking.The line was paused and changed.Chemotherapy drug involved was not provided.No injury reported.
Additional Manufacturer Narrative
Event 1: this report has been identified as b.Braun medical internal report number (b)(4).Three (3) samples in total were returned for evaluation.One sample was used with packaging, two samples were unused with packaging.The used sample was visually inspected per specification and it was noted the lower caresite lure access device (y-site) had a crack on the threads.The used sample was also tested for leakage per specifications with failing results.The remaining two unused samples were tested for leakage per specifications with passing results.Based on the evaluation results the reported defect was confirmed.The exact root cause could not be determined at this time.However, incidents of cracked/leaking valves can 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.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.In addition, review of the batch history records was also performed for the reported lot number and no non-conformances or deviations were noted during the manufacturing process or final inspections.Furthermore, the house retain samples were tested per specifications and no defects were observed.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
• MDR Report Key: 9852797
• Report Number: 2523676-2020-00080
• Device Sequence Number: 2533442
• Product Code: FPA
• UDI-Device Identifier: 04046964823428
• UDI-Public: 04046964823428
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K153293
• 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): 04/29/2020

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: 09/30/2022
• Device Model Number: 470195
• Device Catalogue Number: 470195
• Device Lot Number: 0061700009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Initial Date Received by Manufacturer: 03/05/2020
• Supplement Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 03/19/2020
• Supplement Report FDA Received Date: 04/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR