MAUDE Adverse Event Report: B. BRAUN DOMINICIAN REPULIC INC. ULTRASITE®; SET, ADMINISTRATION, INTRA

Catalog Number	US1921
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/24/2019
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, 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 during a chemotherapy infusion, the product leaked causing chemo to drip on the floor.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Two (2) photos were provided by the facility for evaluation.Visual examination of the photo had leakage observed between the luer connector adapter of the secondary set and the caresite of a different set.Although the defect was noted via the photo, a thorough investigation could not be performed.One (1) unopened sample identifying the reported lot # 61663638 was returned for evaluation.The returned sample was tested for leakage per specification with passing results.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.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: ULTRASITE®
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN DOMINICIAN REPULIC INC.; las americas industrial park; km22 autopista las americas; DR
• MDR Report Key: 8690982
• Report Number: 9614279-2019-00089
• Device Sequence Number: 11246708
• Product Code: FPA
• UDI-Device Identifier: 04046964187971
• UDI-Public: 04046964187971
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K955585
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/29/2019

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: US1921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Initial Date Received by Manufacturer: 05/24/2019
• Supplement Date Received by Manufacturer: 05/24/2019
• Initial Report FDA Received Date: 06/12/2019
• Supplement Report FDA Received Date: 07/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1