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

Catalog Number	490438
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Although it was confirmed that the device involved is not available for evaluation, 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: blood set tubs are leaking excessively and fittings are snapping.Fluid is leaking at the bifurcation and/or the tubing at the bifurcation completely comes apart.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The actual defective device was not received for evaluation.Retain samples for catalog 490438, lot 0061652783 were visual and functionally tested.Based on the evaluation results,1 out of 6 retain samples were found with leakage.The reported defect of leakage was confirmed.Per the manufacturer's statement, the defect is due to insufficent glue during the assembly process.In response to this incident and other incidents of this nature, the manufacturer has added new visual and written instructions to their procedure to ensure proper assembly.As a result of the retain failure for leakage, the house retain samples were also visually and fucntinoally tested for the before lot 0061649378 and after lot 0061658664.Lot 0061649378 was found acceptable; however, for lot 0061658664, 1 out of 5 units was found to have foreign matter/particulate in the fluid path.Please note, that mfr report number 9614279-2019-00191 will be filed for the confirmed defect of "foreign matter/particulate." furthermore, a 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.

• 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: 8793008
• Report Number: 9614279-2019-00110
• Device Sequence Number: 1977582
• Product Code: FPA
• UDI-Device Identifier: 04046964833441
• UDI-Public: 04046964833441
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K083723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• 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: 11/30/2021
• Device Catalogue Number: 490438
• Device Lot Number: 0061652783
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/25/2019
• Supplement Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 07/16/2019
• Supplement 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