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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES FIRST PICC S/L 18GA (4F) 1.35MM X 65CM

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ARGON MEDICAL DEVICES FIRST PICC S/L 18GA (4F) 1.35MM X 65CM Back to Search Results
Model Number 384157
Device Problem Material Perforation (2205)
Patient Problem Insufficient Information (4580)
Event Date 07/21/2021
Event Type  malfunction  
Manufacturer Narrative
The sample is unavailable for evaluation. Without such evidence to review, the complaint cannot be confirmed. If additional information is received in the future, a follow-up report will be submitted.
 
Event Description
According to the nursing report: "picc was passed, and after tracing the guide wire and salinizing the catheter, it was observed that it was perforated near the oval disc".
 
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Brand NameFIRST PICC S/L 18GA (4F) 1.35MM X 65CM
Type of DeviceFIRST PICC
Manufacturer (Section D)
ARGON MEDICAL DEVICES
1445 flat creek rd
athens TX 75751
MDR Report Key12319702
MDR Text Key268024068
Report Number0001625425-2021-01062
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00886333209682
UDI-Public00886333209682
Combination Product (y/n)N
PMA/PMN Number
K972262
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial
Report Date 08/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model Number384157
Device Catalogue Number384157
Device Lot Number11317182
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/30/2021
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

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