MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 13.5F X 20CM SILICONE CATH; HEMO-CATH ST

Model Number ECS1320

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 11/08/2019

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated.We are currently waiting for additional information and the return of the device sample for evaluation.

Event Description

At approximately 10:30 am patient started bleeding from vascath.Sister and dr informed.Dressing removed and on inspection blood was coming from a hole in the vascath tubing itself below the blue fixing limb which is stitched in.Dr removed the vascath and inserted a new one in its place.

Manufacturer Narrative

Photographs taken under magnification show the hole in the arterial side of the lumen.The edges of the cut are smooth which is indicative of a cut with a sharp instrument instead of jagged which would be an indication of a lumen burst.It was determined that the most likely root cause of the leak is a cut with a sharp instrument, not a manufacturing issue.This product family of devices is 100% leak tested during manufacturing.

• Brand Name: 13.5F X 20CM SILICONE CATH
• Type of Device: HEMO-CATH ST
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 9494625
• MDR Text Key: 204049746
• Report Number: 2518902-2019-00079
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00541376500526
• UDI-Public: 541376500526
• 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: 01/26/2020

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: ECS1320
• Device Catalogue Number: ECS1320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/19/2019
• Supplement Dates Manufacturer Received: 12/06/2019
• Supplement Dates FDA Received: 01/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention