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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM
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ARGON MEDICAL DEVICES L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM Back to Search Results
Model Number 384539
Device Problem Crack (1135)
Patient Problem Insufficient Information (4580)
Event Date 01/23/2023
Event Type  malfunction  
Event Description
Left peripherally inserted central line catheter (picc) requiring clave change.Plan was to remove clave under sterile conditions and replace with t-connector instead of a clave to relieve weight on catheter, possibly contributing to cracked hubs.Clinical educator present to take pics for teaching purposes.Clave removed carefully and t-connector placed and dlushed without incident, after line had bleed back slightly.Dressing underneath was wet after changing connector, requiring a dressing change.After assembling equipment for dressing change line had bleed back.Attempted to flush, but the hub was cracked and the flush sprayed out of the hub.Appeared that the hub may have cracked during the clave change, and the initial flush was what had made the dressing wet---the hub was maybe at a different angle so not as obvious.
 
Manufacturer Narrative
It is unknown if sample will get returned for investigation or not.A follow-up report will be submitted once new information becomes available.
 
Manufacturer Narrative
A review of the dhr and inspection records could not be conducted since a lot number was not provided.After three notifications, there has been no sample returned for review.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.Without such evidence, the results are inconclusive and determining a definite root cause and corrective action is not possible.If the sample is returned at a future date, this complaint will be reopened for further evaluation at that time.
 
Event Description
Left peripherally inserted central line catheter (picc) requiring clave change.Plan was to remove clave under sterile conditions and replace with t-connector instead of a clave to relieve weight on catheter, possibly contributing to cracked hubs.Clinical educator present to take pics for teaching purposes.Clave removed carefully and t-connector placed and dlushed without incident, after line had bleed back slightly.Dressing underneath was wet after changing connector, requiring a dressing change.After assembling equipment for dressing change line had bleed back.Attempted to flush, but the hub was cracked and the flush sprayed out of the hub.Appeared that the hub may have cracked during the clave change, and the initial flush was what had made the dressing wet---the hub was maybe at a different angle so not as obvious.¿.
 
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Brand Name
L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM
Type of Device
L-CATH PICC
Manufacturer (Section D)
ARGON MEDICAL DEVICES
1445 flat creek rd
athens TX 75751
Manufacturer Contact
elnaz rahman
1445 flat creek rd
athens, TX 75751
9036759321
MDR Report Key16457346
MDR Text Key310413343
Report Number0001625425-2023-00977
Device Sequence Number1
Product Code LJS
UDI-Device Identifier00886333209934
UDI-Public00886333209934
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091670
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/25/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number384539
Device Catalogue Number384539
Device Lot Number11441589
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/14/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/20/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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