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U.S. Department of Health and Human Services

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

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ARGON MEDICAL, INC. CATHETER, INTRAVASCULAR INTRACATH Back to Search Results
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.
 
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Brand NameCATHETER, INTRAVASCULAR
Type of DeviceINTRACATH
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 Key8297501
MDR Text Key134855690
Report Number1625425-2019-00019
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K821372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
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
Date FDA Received02/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number384904
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report to Manufacturer01/10/2005
Date Manufacturer Received01/10/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 02/01/2019 Patient Sequence Number: 1
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