MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 12F X 20CM DUO FLOW; DUO-FLOW HEMODIALYSIS CATHETER

Model Number XTP128MT=

Device Problem Separation Problem (4043)

Patient Problem No Information (3190)

Event Date 10/08/2020

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated.We are currently waiting for additional information and the sample 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 had a right femoral dialysis catheter which he had pulled out.The sutures and suture hub were still in place but the catheter was out.

Manufacturer Narrative

The duo-flo catheter was returned for evaluation.Visual inspection confirms the complaint as the suture wing was not attached to the catheter hub.The blue hub shows no stress or damage.In the left side of the hub it can be observed that the beveled edge used when inserting the wing is intact.The 90 degree edge at the end of the bevel is also intact.This angle prevents the wing body from moving position and keeps the lumen inside the wing.It appears that enough force was applied to the catheter to dislodge it from the suture wing.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their review showed the device was manufactured according to specification with no non-conformances or abnormalities.During product verification and validation testing the force of break between the suture wing and hub was tested in accordance with iso standards.A definitive root cause cannot be determined but is most likely not manufacture 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: 12F X 20CM DUO FLOW
• Type of Device: DUO-FLOW HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 10734073
• MDR Text Key: 213020248
• Report Number: 2518902-2020-00052
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00884908060232
• UDI-Public: 884908060232
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 12/29/2020

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?: Yes
• Device Operator: Other
• Device Model Number: XTP128MT=
• Device Catalogue Number: XTP128MT=
• Device Lot Number: MPCC690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/26/2020
• Initial Date FDA Received: 10/26/2020
• Supplement Dates Manufacturer Received: 10/26/2020
• Supplement Dates FDA Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention