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

Model Number 456020

Device Problem Leak/Splash (1354)

Patient Problem Inadequate Pain Relief (2388)

Event Date 09/26/2022

Event Type  malfunction  

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 Description

As reported by the user facility: stopcock found to be leaking.Sedation had been infusing and patient was extremely agitated.Once stopcock replaced, patient was receiving adequate does of sedation and was now calm.No injury reported.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).One (1) used sample with the packaging was returned for evaluation.The sample was subject to a visual and physical evaluation with passing results.No leakage was observed on the discofix.Based on the evaluation results, the reported defect was not confirmed.Retained units were evaluated and passed the internal testing.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®
• Type of Device: 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: 15632719
• MDR Text Key: 306706686
• Report Number: 2523676-2022-00514
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 04046964996962
• UDI-Public: (01)04046964996962
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K760383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 456020
• Device Catalogue Number: 456020
• Device Lot Number: 21G09D9045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1