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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES L-CATH PICC S/L 28GA (1.2F) X 25CM

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ARGON MEDICAL DEVICES L-CATH PICC S/L 28GA (1.2F) X 25CM Back to Search Results
Model Number 28 GA (1.2F) X 25CM
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Foreign Body In Patient (2687)
Event Date 02/01/2021
Event Type  malfunction  
Manufacturer Narrative
The sample is expected to return for evaluation. A follow-up report will be submitted once the sample has been received and reviewed.
 
Event Description
Second picc line to get stuck inside the same baby. The first having broken in the saphenous vein and being the subject of complaint (b)(4). The picc line of the current complaint remained stuck in the left cephalic vein. Unsuccessful attempt at post-technical alteplase withdrawal. Consultations in vascular surgery and pediatric cardiology, cariac ultrasound and doppler performed. Picc removed in a hemodynamic room under fluoroscopy with a pediatric cardiology team. So many investigations / consultations. Parental concerns since the removal of the first incarcerated picc line required vascular surgery and general anesthesia.
 
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Brand NameL-CATH PICC S/L 28GA (1.2F) X 25CM
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 Key11455853
MDR Text Key242909426
Report Number1625425-2021-00862
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00886333209910
UDI-Public00886333209910
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 Number28 GA (1.2F) X 25CM
Device Catalogue Number384516
Device Lot Number11308071
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
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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