MAUDE Adverse Event Report: B. BRAUN DOMINICIAN REPULIC INC. BLOOD ADMINISTRATION SET; SET, ADMINISTRATION, INTRA

Catalog Number	490438
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The retain samples for the before lot number (0061662332) were visually and functionally tested and no defects were noted.Further testing was performed on the before lot and no foreign matter was identified.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.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.
Event or Problem Description
This report is being filed due to retain samples failing visual inspection during testing: based on the evaluation results the manufacturing site stated that one (1) out of five (5) units was found to have foreign matter in the fluid path.

• Brand Name: BLOOD ADMINISTRATION SET
• 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: 9176307
• Report Number: 9614279-2019-00191
• Device Sequence Number: 2774617
• Product Code: FPA
• UDI-Device Identifier: 04046964833441
• UDI-Public: 04046964833441
• Combination Product (Y/N): N
• PMA/510(K) Number: K083723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/10/2019

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: 12/31/2021
• Device Catalogue Number: 490438
• Device Lot Number: 0061658664
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 10/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1