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

Model Number	601278-02
Medical Device Problem Codes	Obstruction of Flow (2423); Difficult to Advance (2920)
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: 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.
Additional 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.
Additional 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
• Common Device Name: 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
• Report Number: 2523676-2022-00491
• Device Sequence Number: 20347754
• Product Code: DYG
• UDI-Device Identifier: 04046955651634
• UDI-Public: (01)04046955651634
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K822806
• 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): 11/03/2022

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 Model Number: 601278-02
• Device Catalogue Number: 601278-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2022
• Supplement Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown