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

Catalog Number	US1921
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).As confirmed by the user facility, a sample will not be returned for evaluation.The investigation is ongoing at this time.A follow-up report will be submitted when the results of the investigation become available.
Event or Problem Description
As report by the user facility: the nurse observed chemotherapy on the surface of the secondary tubing.No injuries were reported.Limited information was provided.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).As confirmed by the user facility, a sample was not available for evaluation.Three (3) pictures were provided for evaluation.However, leakage from the ultrasite area could not be confirmed through examination of the three returned photos.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or non-conformances of this nature.Without the actual device, a thorough investigation could not be performed and the exact root cause 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: ULTRASITE®
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN DOMINICAN REPUBLIC INC.; las americas industrial park; km22 autopista las americas; santo domingo, ; DR
• MDR Report Key: 8077762
• Report Number: 9614279-2018-00196
• Device Sequence Number: 262763
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2018

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 Catalogue Number: US1921
• Device Lot Number: 0061593656
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/29/2018
• Supplement Date Received by Manufacturer: 10/29/2018
• Initial Report FDA Received Date: 11/16/2018
• Supplement Report FDA Received Date: 12/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1