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

Model Number ECS1320

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Exsanguination (1841)

Event Date 03/02/2021

Event Type  Death  

Manufacturer Narrative

An investigation has been initiated.Currently waiting for the device to be returned for evaluation.

Event Description

Catheter became separated from winged stabilisation device.Catheter was then dislodged from vein leaving stabilisation device attached by sutures to skin.This resulted in a catastrophic haemorrhage.Cpr unsuccessful.Reason for late reporting: time period for internal level 1 investigation, internal delay following up with the company it was initially thought the product came from, delay it identifying the correct make / brand of the product.

Manufacturer Narrative

The silicone catheter was returned for evaluation.The suture wing was not attached to the catheter and was not returned.A functional examination of the device revealed it could not be flushed through the arterial luer.The portion of the hub to which the suture wing attaches appears intact with no damage or abnormalities.Measurements were taken of the hub and found the notch were within specification.The contract manufacturer conducted a review of the manufacture records.Their investigation revealed the device was manufactured and inspected according to specification with no non-conformances or abnormalities.This process includes a 100% inspection to ensure the correct placement of the suture wing on the catheter hub.When attaching the suture wing to the hub, the operator must push firmly until the suture wing has entered the slot and is secured.After the suture wing is assembled onto the hub, it is rotated several times to ensure free movement and proper positioning on the hub.A review of the engineering verification testing noted that all samples tested passed the suture wing pull force requirements of 3.38 pounds per the iso standard with a tested minimum of 7.13 pounds.Without an evaluation of both pieces of the device a root cause cannot be determined.However, it appears that enough force was applied to the catheter to dislodge it from the suture wing.

• 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
• Manufacturer (Section G): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 14601765
• MDR Text Key: 293347947
• Report Number: 2518902-2022-00037
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00541376500526
• UDI-Public: 541376500526
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/12/2022

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
• Device Lot Number: MNVW720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/31/2022
• Initial Date FDA Received: 06/06/2022
• Supplement Dates Manufacturer Received: 05/31/2022
• Supplement Dates FDA Received: 08/12/2022
• 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): Death
• Patient Age: 86 YR
• Patient Sex: Male