MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 12.5FX24CM HEMO-CATH

Model Number MC101243

Device Problem Backflow (1064)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/27/2020

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 avail able for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

When catheter is run in the normal direction arterial to venous, at that start of dialysis saline is aspirated from the arterial line that is only slightly blood tinged.It appears as if there is a communication between the arterial and venous lumens.The catheter seems to work when run in reverse, though with significant recirculation.

Manufacturer Narrative

Received one 12.5f x 24cm silicone double lumen catheter is two pieces.The lumen is cut 1.2cm distal to the hub.The internal section of the lumen includes the cuff which has evidence of tissue ingrowth.No abnormalities or defects are visually evident on any part of the device.Both the arterial and venous sides aspirated and flushed without resistance.There is no evidence of a cross lumen leak.The reported failure could not be replicated.No device failure was found.We are unable to determine the cause or factors that may have contributed to this event.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: 12.5FX24CM HEMO-CATH
• Type of Device: HEMO-CATH
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 9996461
• MDR Text Key: 195748909
• Report Number: 2518902-2020-00021
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908083002
• UDI-Public: 884908083002
• Combination Product (y/n): N
• PMA/PMN Number: K113487
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2023
• Device Model Number: MC101243
• Device Catalogue Number: MC101243
• Device Lot Number: MMBH030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/30/2020
• Date Manufacturer Received: 05/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 15 YR
• Patient Weight: 49