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

Catalog Number	456003
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: details of complaint (reported issue): "we have a group of these 3 way stopcocks received that are defective.If you look closely there is a defect on the tip that attaches to the patients iv line.This is the first batch we have seen that are defective." no injury reported.
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.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Two photographs were provided for investigation.Upon evaluation of the photographs, it was observed the three- way stopcock had a molding defect.The reported concern was confirmed.Without the actual sample the cause of the deformed male luer cannot be clarified conclusively.The review of the manufacturing documentation revealed that no irregularities or deviations occurred during batch production.The retained samples were evaluated, and visual inspection showed that all samples met the requirements and no irregularities were detected.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.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) sample and two (2) photos were submitted to the manufacturer for evaluation.Through visual examination of the photos and sample, it was observed that the three-way stopcock has a defect to the tip of the male lure.A deformation at the lla-cone was observed.The sample is not within specification; the reported defect is confirmed.Retained samples were checked and visual inspection showed that all samples met the requirements and no irregularities were detected.While the reported defect was observed, an exact root cause could not be determined.Further evaluation is taking placed based on this complaint/defect.A review of the non-conformance system database was performed for the reported lot number and no abnormalities or nonconformances 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: 21263969
• Report Number: 2523676-2025-00027
• Device Sequence Number: 9538576
• Product Code: KGZ
• UDI-Device Identifier: 04046964183577
• UDI-Public: (01)04046964183577(11)240801(17)270501(10)24E26D9041
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/22/2025

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 Catalogue Number: 456003
• Device Lot Number: 24E26D9041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 03/12/2025; 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• 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