MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. CORODYN; CATHETER, FLOW DIRECTED

Model Number 601278-02

Device Problems Obstruction of Flow (2423); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

As reported by the user facility: event 3: event description:could not get an 025 wire (and they mentioned 018" as well) through the endhole of the catheters on several different occasions.Also, the doctor said he tried using an.025" tip delecting wire and it wouldn't go to the endhole even.He said it stopped a good amount before the endhole (1cm?) and definitely wouldn't go through so he wasn't able to deflect the tip of the catheter.

Manufacturer Narrative

This report has been identified as b.Braun medical.Internal report number (b)(4).Event 3 the complaint is under evaluation.A follow-up report will be provided after the examination results are available.

Manufacturer Narrative

Event 3: this report has been identified as b.Braun medical internal report number (b)(4).No sample and/or lot number were provided.Further investigation of the complaint is not possible without a sample and/or lot number.The actual defective device is valuable tool in investigating the cause of this incident.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: CORODYN
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 861 marcon blvd.; allentown PA 18109
• Manufacturer (Section G): B. BRAUN MEDICAL INC.; 861 marcon blvd.; allentown PA 18109
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 15519385
• MDR Text Key: 306247238
• Report Number: 2523676-2022-00491
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 04046955651634
• UDI-Public: (01)04046955651634
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K822806
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 601278-02
• Device Catalogue Number: 601278-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1