MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. DUAL CATH, METHODE B. CANAUD

Model Number MCCC1040K-A

Device Problem Leak/Splash (1354)

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

Event Date 12/09/2021

Event Type  malfunction  

Event Description

Venous catheter split lengthwise, possibly during vomiting.

Manufacturer Narrative

Currently waiting for the device to be returned for evaluation.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

The venous and arterial catheters were returned for evaluation.Visual inspection revealed the arterial catheter is intact and functions as designed.The venous catheter lumen is torn beginning from the suture used to secure the lumen to the adapter continuing to the end of the adapter barb, approximately 1.5 cm.It appears the tip of the adapter barb poked through the lumen resulting in the tear.The contract manufacturer conducted a review of the manufacture process for the lot number reported.Their investigation revealed the device was manufactured and inspected according to specification with no non-conformances or abnormalities.A definitive root cause cannot be determined but is not likely manufacture related.The catheter was implanted for over 2 months with no reported issue.It is possible the internal lumen wall was slightly damaged during the insertion procedure when attaching the lumen to the adaptor.With the suture secured tightly around the lumen and adaptor, the patient's reported effort of vomiting resulted in the lumen tear.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DUAL CATH, METHODE B. CANAUD
• Type of Device: CANAUD
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: lynn winkler ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 13010346
• MDR Text Key: 285739871
• Report Number: 2518902-2021-00070
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 84908025972
• UDI-Public: 84908025972
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MCCC1040K-A
• Device Catalogue Number: MCCC1040K-A
• Device Lot Number: MMFW510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 80 KG