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

Catalog Number	490321
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One, opened, used sample was received without packaging in conjunction with this complaint.This sample was visually examined and no manufacturing defects were noted.The returned product was functionally tested and confirmed the reported defect of leakage from the backcheck valve.The sample was further examined by manufacturing business unit leaders and engineers.It was confirmed that the sonic weld of the product was not a complete seal.The exact root could not be determined at this time.The backcheck valve is made with a brittle material and when excess pressure is applied it is likely to cause cracks, resulting in leakage or complete breakage of the sonic weld.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or non-conformances of this nature.While we are unable to confirm the exact root cause of the reported defect, we will maintain this report for further references and continue to monitor other reports for similar occurrences.Note: this case is being filed retrospectively as a result of a review of recent customer complaint information.Based on a new complaint case and an updated procedure, it was determined that this case is reportable in accordance with the requirements of 21 cfr 803.B.Braun has conducted a retrospective review for all complaints of similar nature in accordance with b.Braun internal procedures.
Event or Problem Description
As reported by the user facility: during priming several sets leaked at the backcheck valve.No patient injury reported.

• Brand Name: BLOOD ADMINISTRATION SET
• 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: 7274437
• Report Number: 9614279-2018-00031
• Device Sequence Number: 13488678
• Product Code: FPA
• UDI-Device Identifier: 04046964540363
• UDI-Public: 04046964540363
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K931377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/15/2018

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: 10/31/2019
• Device Catalogue Number: 490321
• Device Lot Number: 0061404357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2015
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2015
• Initial Report FDA Received Date: 02/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1