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)
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: the ultrasite leaked and chemo dripped on the floor.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) unopened set identifying lot # 0061661177 was received for further evaluation.A visual, leakage, and iso tapper test was performed on the returned sample per specification, and no defects were found.In addition a leakage and tapper luer test was performed 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: 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: 8882732
• Report Number: 9614279-2019-00121
• Device Sequence Number: 13929039
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2019

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 Expiration Date: 01/31/2024
• Device Catalogue Number: US1921
• Device Lot Number: 0061661177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2019
• Initial Date Received by Manufacturer: 07/26/2019
• Supplement Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 08/12/2019
• Supplement Report FDA Received Date: 09/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1