MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. CANAUD; CANAUD HEMODIALYSIS CATHETER

Device Problem Leak/Splash (1354)

Patient Problem Unspecified Infection (1930)

Event Date 01/17/2020

Event Type  Injury  

Manufacturer Narrative

Insufficient information was provided for the device and the incident to perform an investigation.

Event Description

Catheter was implanted on (b)(6) 2018.During a dialysis session on (b)(6) 2020, blood flow was observed in the extension line.On (b)(6) 2020, a leak was noted.

Manufacturer Narrative

Due to patient's infectious disease, the device was not returned for evaluation.Photographs provided shows what looks like a small hole in the lumen just below the barbed adaptor, confirming the complaint.The lot number was not provided, and the catalog number of the device was stated as being one of three possible codes.It is not possible to determine which device is involved in this complaint.Without an evaluation of the device with microscopic review of the hole, a root cause cannot be determined.Without a lot number, a review of the manufacture records cannot be conducted.As the device was implanted for 18 months before the issue was noted, the root cause is not likely to be not manufacturing related.Device was used for treatment, not diagnosis.If information is obtained that was not avail able for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CANAUD
• Type of Device: CANAUD HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 9739395
• MDR Text Key: 189476240
• Report Number: 2518902-2020-00009
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 68