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	05/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).No sample was available for further evaluation.Without the actual device and/or lot number, a thorough investigation could not be performed.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.
Event or Problem Description
As reported by the user facility: customer reports that at the end of the infusion drops of epratuzumab were found at the tubing junction below the ultrasite valve.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample was received for further evaluation.Two photos were provided by the facility for evaluation.Visual examination of the provided photo had leakage observed between the luer connector adapter of the secondary set and the caresite of a different set.The reported defect was confirmed.Although the reported defect was confirmed, the exact cause could not be determined without a sample and or lot number to evaluate.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 DOMINICIAN REPULIC INC.; las americas industrial park; km22 autopista las americas; DR
• MDR Report Key: 8704759
• Report Number: 9614279-2019-00092
• Device Sequence Number: 1875784
• 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): 07/30/2019

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 Catalogue Number: US1921
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/23/2019
• Supplement Date Received by Manufacturer: 05/23/2019
• Initial Report FDA Received Date: 06/17/2019
• Supplement Report FDA Received Date: 07/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1