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 (1) photo was submitted for evaluation in connection with this incident.Based on the picture received, the defect was confirmed, as it depicts the set separated at the sonic weld of the backcheck valve.Sample evaluation is an integral part of the investigation process.Without the actual sample, the exact root cause was not determined.Although, the exact root could not be determined at this time.It should be noted that the back check valve, if exposed to excessive pressure may crack, resulting in leakage or complete breakage of the sonic weld.Review of the discrepancy management system (dsms) database performed for the reported lot number revealed no abnormalities or non conformances noted during in process or final product inspection.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: event 3: several of the iv tubing sets, have leaked or are broken apart at the anti-reflux 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: 7274443
• Report Number: 9614279-2018-00022
• Device Sequence Number: 10804176
• Product Code: FPA
• UDI-Device Identifier: 04046964540363
• UDI-Public: 04046964540363
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: 06/29/2021
• Device Catalogue Number: 490321
• Device Lot Number: 0061516670
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2016
• 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