MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. DISCOFIX®; ACCESSORIES, CATHETER

Catalog Number	456020
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).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: rn was trying to do a bubble study and the away stopcock blew apart under pressure.It appears that the end that is a lure lock can't get enough turns on the hub to tightly secure.No patient involvement.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One photograph was provided for evaluation.Upon visual inspection of the photographs, the attached photograph depicted an unused stopcock and included detailed information such as the item, lot number, and expiration date.Additionally, it is noted in the defect description that the end user reported the product failed under pressure.According to the expiration date, the lot provided had expired in november 2024.Therefore, any defects identified in such products cannot be reliably attributed to their original quality or manufacturing processes.Based on the data from the investigation, the reported defect was unable to be confirmed.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: DISCOFIX®
• Common Device Name: ACCESSORIES, CATHETER
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 21091230
• Report Number: 2523676-2024-01191
• Device Sequence Number: 8657010
• Product Code: KGZ
• UDI-Device Identifier: 04046964996962
• UDI-Public: (01)04046964996962(11)220216(17)241101(10)21M09D9044
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K760383
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2025

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: 11/01/2024
• Device Catalogue Number: 456020
• Device Lot Number: 21M09D9044
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown