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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

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ARGON MEDICAL DEVICES FIRST PICC S/L 26GA (1.9F) 0.65MM X 50CM Back to Search Results
Model Number 384232
Device Problem Contamination (1120)
Patient Problem Insufficient Information (4580)
Event Date 04/23/2021
Event Type  malfunction  
Manufacturer Narrative
Sample is unavailable for evaluation. Without such evident to review, the complaint cannot be confirmed. If additional information is provided in the future, a follow-up report will be submitted.
 
Event Description
Picc 1. 9 fr catheter with micro hole in the distal part, 1 cm from the fixator. Verified micro drops at flushing. Material discarded due to be contaminated with blood.
 
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Brand NameFIRST PICC S/L 26GA (1.9F) 0.65MM X 50CM
Type of DeviceFIRST PICC
Manufacturer (Section D)
ARGON MEDICAL DEVICES
1445 flat creek rd
athens TX 75751
Manufacturer Contact
gina liu
1445 flat creek rd
athens, TX 75751
9036759321
MDR Report Key12136583
MDR Text Key262896945
Report Number0001625425-2021-01017
Device Sequence Number1
Product Code FOZ
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 distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number384232
Device Catalogue Number384232
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/08/2021
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

Patient Treatment Data
Date Received: 07/08/2021 Patient Sequence Number: 1
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