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

Model Number MCCC1040K-A

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/09/2022

Event Type  malfunction  

Manufacturer Narrative

We are 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.

Event Description

The patient's nurse found him with a bloody neck bandage.The patient had bled a lot during the night.When the bandage was changed, the nurse noticed that the arterial branch (red) of the canaud catheter had been cut at the skin emergence, or even a little deeper, as the catheter was not visible in the jugular vein.

Manufacturer Narrative

The canaud arterial adapter was returned for evaluation in two pieces.The adapter, clamp, and approximately 2 cm of the lumen attached to the adapter with sutures, as well as 16 cm of the lumen.The suture is wrapped around the adaptor and lumen multiple times and tied very tightly.Visual inspection revealed the lumen tore at the end of the adapter plug.The contract manufacturer conducted a review of the manufacture records 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 lumen may have been slightly damaged during assembly onto the adapter plug or prior to insertion and became worn over time.The catheter was implanted for approximately 18 months with no reported issues.Excessive manipulation during the implant time may have contributed to the incident.The instructions for use contains the following warnings and cautions: use extreme care during assembly of the extension adapter to the lumen in order to avoid damaging the lumen.Care must be taken when using sharp objects or needles in close proximity to catheter lumens.Contact from sharp objects may cause catheter failure.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: 14192250
• MDR Text Key: 289959364
• Report Number: 2518902-2022-00028
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908025972
• UDI-Public: 884908025972
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• 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: MMCK080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2019
• 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: 83 YR
• Patient Sex: Male
• Patient Weight: 79 KG