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

Catalog Number	473447
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Blood Loss (2597)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device involved has not 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: customer reports that they have been having issues with the product leaking where the distal male luer connects to the tubing.The leaking causes blood to back up into the tubing, and customer reports that they had a "bloody mess".No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Forty-five (45) unopened samples and one opened used set were returned for evaluation.In addition, one photo was provided by the facility.The one (1) opened sample and twenty (20) random unopened samples were tested for leakage and 2 of 21 failed.Examination of the distal connectors exhibited excess solvent on the luers of the adapters.All remainder samples were found acceptable.The attached photo was evaluated and it did not confirm leakage or any other defect.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.All available information regarding this occurrence has been forwarded to our material review broad (mrb) business unit leaders and all personnel involved in the manufacturing and inspection of this product in order to heighten awareness.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 DOMINICAN REPUBLIC INC.; las americas industrial park; km22 autopista las americas; santo domingo, ; DR
• MDR Report Key: 8422564
• Report Number: 9614279-2019-00016
• Device Sequence Number: 14035351
• Product Code: FPA
• UDI-Device Identifier: 04046964185342
• UDI-Public: 04046964185342
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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): 05/29/2019

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 Expiration Date: 09/30/2023
• Device Catalogue Number: 473447
• Device Lot Number: 0061644135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Initial Date Received by Manufacturer: 02/28/2019
• Supplement Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 03/14/2019
• Supplement Report FDA Received Date: 05/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1