MAUDE Adverse Event Report: ARGON MEDICAL, INC. CATHETER, INTRAVASCULAR; INTRACATH

Model Number N/A

Device Problems Break (1069); Device Slipped (1584)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 01/05/2019

Event Type  Injury  

Manufacturer Narrative

A review of returned product from the customer was performed, visual inspection of the sample returned from the customer found catheter tube was broken or cut, found flared end of the tube catheter fully assembled with the hub.According to the tubing drawing length is 13.875-14.125, returned tube measured 6", so bottom part of the tube found broken (bottom cutting tube not returned with the sample.Functionally reviewed the sample, unable to identify if the tube is cut or pulled with excessive force, material is very soft from the damage to the catheter tube.During lab testing, this event could not be duplicated.At this time we are unable to identify how the catheter tube broke and flared out and the complaint was confirmed.The root cause of this issue, unable to be verified.At this time this complaint is only confirmed, catheter tube broken and flared out.This issue has been documented will continue to be tracked and monitored in the future.

Event Description

It was reported that upon removal of the intracath only part of the catheter came out.The catheter was not cut but appeared to have broken or snapped without physical force.The remainder of the catheter had to be surgically removed from the patient.

• Brand Name: CATHETER, INTRAVASCULAR
• Type of Device: INTRACATH
• Manufacturer (Section D): ARGON MEDICAL, INC.; 1445 flat creek road; athens TX 75751
• Manufacturer (Section G): ARGON MEDICAL, INC.
• Manufacturer Contact: gail smith ; 1445 flat creek road; athens, TX 75751 ; 9036759321
• MDR Report Key: 8297501
• MDR Text Key: 134855690
• Report Number: 1625425-2019-00019
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K821372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/01/2005,02/01/2019

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 384904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 01/10/2019
• Initial Date FDA Received: 02/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other