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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES FIRST PICC S/L 26GA (1.9F) 0.65MM X 50CM WITH STATLOCK STABILIZATION DEVICE
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ARGON MEDICAL DEVICES FIRST PICC S/L 26GA (1.9F) 0.65MM X 50CM WITH STATLOCK STABILIZATION DEVICE Back to Search Results
Model Number 384242
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 03/13/2024
Event Type  malfunction  
Manufacturer Narrative
The sample is not available for return.The investigation is currently in progress.A follow-up report will be submitted upon investigation completion.
 
Event Description
Reporter indicated they placed a1.9 fr single lumen picc on neonate for the inpatient peds floor and has broken just prior to the disc under the tegaderm using the statlock on (b)(6) 2024.
 
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Brand Name
FIRST PICC S/L 26GA (1.9F) 0.65MM X 50CM WITH STATLOCK STABILIZATION DEVICE
Type of Device
FIRST PICC S/L
Manufacturer (Section D)
ARGON MEDICAL DEVICES
1445 flat creek rd
athens TX 75751
Manufacturer Contact
kelly mayer
1445 flat creek rd
athens, TX 75751
9036759321
MDR Report Key19189251
MDR Text Key341460714
Report Number0001625425-2024-00998
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00886333209774
UDI-Public00886333209774
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K972262
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/26/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number384242
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/27/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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