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

Catalog Number	471954
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	06/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device involved has not 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: the luer lock connector of the extension line was ripped and blood leaked.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Four (4) extension sets in open packaging were returned in connection with this complaint.A picture of a used extension set showing just the side clamp and tubing was also returned.The returned sets were visually inspected and no defects were found.The sets were then pressure tested per specification with passing results.The returned picture, however, was visually inspected and noted a cut on the tubing near the side clamp.The set was noted to be used and filled with blood.Although the returned sets passed evaluation, the returned picture can be confirmed for the reported defect.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: EXTENSION 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: 8793007
• Report Number: 9614279-2019-00108
• Device Sequence Number: 2540055
• Product Code: FPA
• UDI-Device Identifier: 04022495770103
• UDI-Public: 04022495770103
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K942988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2019

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: 08/31/2023
• Device Catalogue Number: 471954
• Device Lot Number: 0061641918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 07/16/2019
• Supplement Report FDA Received Date: 08/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1