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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 26GA (1.9F) X 30CM
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problems Vasodilatation (2127); Foreign Body In Patient (2687); Insufficient Information (4580)
Event Date 12/24/2020
Event Type  malfunction  
Manufacturer Narrative
The sample is indicated as available for evaluation. As of the date of this report, the sample has not yet been returned. A follow-up report will be submitted once it has been received and reviewed.
 
Event Description
"picc line fractured upon removal. Picc was difficult to remove and the x-ray showed no kinks or knotting. Warm packs were applied to help with vasodilation. Picc was gently removed by vascular access without resistance. Upon removal, it was noted that only 20cm of the catheter (original length was 23cm). Called to bedside to help remove 1. 9 picc that was being pulled; but it would not come out. The picc was placed several months earlier. After assessment, i found picc difficult to remove, and asked md to order x ray of lower extremities and abdomen to evaluate the line for possible kinking, knotting, etc. At the same time i applied heat packs to the right lower extremity to promote vasodilation. Once it was confirmed by the x-ray that there were no kinks in the picc line and no knotting, and the heat was already applied, i gently tried to remove picc. I was able to remove approximately 20 cm of indwelling picc without resistance (per original note the picc length was 23 cm). Then i asked for another x-ray of abdomen and right lower extremity (rle) to be ordered to rule out catheter fracture. Once the x-ray was complete, i notified the ir on call doctor and updated her on the patient status (no changes in clinical status of the patient observed). Primary team was also present on the unit and were notified of the ongoing development. Per doctor (ir) the plan is for ir to remove indwelling picc. Primary team verbalized that they will notify family. ¿.
 
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Brand NameL-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM
Type of DeviceL-CATH PICC
Manufacturer (Section D)
ARGON MEDICAL DEVICES
1445 flat creek rd
athens TX
Manufacturer Contact
gina liu
1445 flat creek rd, athens, tx 75751
MDR Report Key11455857
MDR Text Key241779717
Report Number1625425-2021-00863
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K091670
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 03/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number26GA (1.9F) X 30CM
Device Catalogue Number384539
Device Lot Number11287864
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/10/2021 Patient Sequence Number: 1
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