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

Model Number	V1402
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The device involved has 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: it was reported that a piece of black particulate was seen in the iv tubing.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) unused b braun four-way stopcock set with a cut segment of tubing attached by a luer adapter was provided.In addition a segment of cut tubing taped to a paper listing lots: 0061681720, 0061697536, 0061690622 were also provided.Visual examination of the sample noted a small black particulate underneath the tape.However due to the condition of the sample it is difficult to determine where the material originated.The unused stopcock was also examined with no defects noted.The black particulate was submitted for ftir analysis; however, the amount of material was insufficient and was unable to be tested.Review of the discrepancy management system (dsms) database was performed for the reported lot numbers 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.Information for the additional provided lots are as follows: lot number: 0061681720; production date: 06/18/2019; expiry date: 06/18/2022.Lot number: 0061697536; production date: 09/25/2019; expiry date: 09/25/2022.Lot number: 0061690622; production date: 08/15/2019; expiry date 08/15/2022.

• Brand Name: IV 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: 9569573
• Report Number: 9614279-2019-00230
• Device Sequence Number: 13586935
• Product Code: FPA
• UDI-Device Identifier: 04046964188190
• UDI-Public: 04046964188190
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K790062
• 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): 02/20/2020

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 Model Number: V1402
• Device Catalogue Number: V1402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1