MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	473041
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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: a longitudinal crack was found on the female luer, causing minimal blood leakage.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) used sample with no packaging was returned for evaluation.In addition one photo was provided by the customer for evaluation.Upon visual examination of the sample and photograph, a vertical crack was observed on one of the three female luer lock connectors of the set.The reported defect was confirmed.Additional testing was performed and no defects were noted durning testing.Although the reported defect was confirmed, the exact cause could not be determined.We will maintain this report for further references and continue to monitor other reports for similar occurrences.Since a lot number was not provided a review of the discrepancy management system (dsms) database was unable to be performed.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown 18109
• MDR Report Key: 8634006
• Report Number: 9614279-2019-00075
• Device Sequence Number: 1643796
• Product Code: FPA
• UDI-Device Identifier: 04022495770202
• UDI-Public: 04022495770202
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K942988
• 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): 07/31/2019

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 Catalogue Number: 473041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Initial Date Received by Manufacturer: 05/07/2019
• Supplement Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 07/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1