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
(b)(4).Although the device involved was confirmed not to be available, a photo was provided and the investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.It should be noted that two possible lot numbers were provided; however, it is unknown at this time which lot number was involved in the reported incident.Possible lot number: lot number 0061663638 - production date: 02/19/2019 - expiry date: 01/31/2024.Lot number 0061661177 - production date: 02/08/2019 - expiry date: 01/31/2024.
Event or Problem Description
As reported by the user facility: it was reported that the secondary tubing was leaking at the y-site.Patient was receiving doxorubicin iv, during the rinse of the chemo, it was noticed that chemo was leaking from the y ultrasite on the secondary tubing.Approximately 10 ml was noticed on the iv pose and the tubing - as well as drops on the floor.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Two photos were provided by the facility for evaluation.Visaul 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 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.Retain samples for catalog us1921, lot 0061663638 were visual and functionally tested per specification.Leakage could not be confirmed in the retain samples testing.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 DOMINICIAN REPULIC INC.; las americas industrial park; km22 autopista las americas; DR
• MDR Report Key: 8704758
• Report Number: 9614279-2019-00090
• Device Sequence Number: 2387054
• 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): 08/28/2019

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: 05/29/2019
• Supplement Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 06/17/2019
• Supplement Report FDA Received Date: 08/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1