MAUDE Adverse Event Report: MEDCOMP DUAL CATH, METHODE B. CANAUD

Model Number MCCC1040K-A

Device Problem Disconnection (1171)

Patient Problem Blood Loss (2597)

Event Date 01/29/2019

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated.

Event Description

Patient was connected by a nurse and a care assistant without any difficulty during the connection.Ninety (90) minutes later, patient was found with a decreased alertness.A blood leak at the level of the venous connection was noted; the adaptor was partially unscrewed.Patient required prc (packed red blood cell) transfusion after loss of 100cc of blood.

Manufacturer Narrative

The hemodialysis treatment uses the catheter and a blood tubing set manufactured by a different company (fresenius).Without an evaluation of the device involved it cannot be determined if there is a catheter issue or an issue with the blood tubing set.It is also possible a good connection was not made during the initiation of the treatment.

• Brand Name: DUAL CATH, METHODE B. CANAUD
• Type of Device: CANAUD
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 8495594
• MDR Text Key: 141336206
• Report Number: 2518902-2019-00022
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908025972
• UDI-Public: 884908025972
• 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: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2022
• Device Model Number: MCCC1040K-A
• Device Catalogue Number: MCCC1040K-A
• Device Lot Number: MCFR670
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS BLOOD TUBING; FRESENIUS BLOOD TUBING
• Patient Outcome(s): Required Intervention