MAUDE Adverse Event Report: MEDCOMP 13F X 20CM DUO-FLOW III; DUO-FLOW III STEP TIP CATHETER

Model Number DFST138MTE

Device Problem Disconnection (1171)

Patient Problem Blood Loss (2597)

Event Date 10/15/2018

Event Type  Injury  

Manufacturer Narrative

Currently waiting for additional information and the sample for evaluation.

Event Description

When washing the patient, the catheter went out through the safety ring that is sewn on the patient's skin on 2 locations although absolutely no strength was used.The safety ring stayed on the patient.The whole prisma kit (200 ml of blood) was lost for an ecmo patient with anemia and thrombopenia.A manual compression has been done for 30 min, a transfusion of 2 rbcs and 8 units of platelets, insertion of a new dialysis catheter and use of a new prisma set of tubing.

• Brand Name: 13F X 20CM DUO-FLOW III
• Type of Device: DUO-FLOW III STEP TIP CATHETER
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDCOMP; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 8064395
• MDR Text Key: 126943537
• Report Number: 2518902-2018-00058
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908104981
• UDI-Public: 884908104981
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: DFST138MTE
• Device Catalogue Number: DFST138MTE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/15/2018
• Initial Date FDA Received: 11/13/2018
• Supplement Dates Manufacturer Received: 10/15/2018
• Supplement Dates FDA Received: 06/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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