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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES FIRST PICC SILICONE SINGLE LUMEN 26GA (1.9F) X 50 CM

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ARGON MEDICAL DEVICES FIRST PICC SILICONE SINGLE LUMEN 26GA (1.9F) X 50 CM Back to Search Results
Model Number 384221
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/01/2020
Event Type  malfunction  
Manufacturer Narrative
The sample was returned for evaluation. The investigation is ongoing. A follow-up report will be provided once the investigation is complete.
 
Event Description
Doctor noticed fracture of the catheter at the junction of the hub and catheter during post picc insertion. The catheter was used for i. V drip while waiting for tpn.
 
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Brand NameFIRST PICC SILICONE SINGLE LUMEN 26GA (1.9F) X 50 CM
Type of DeviceFIRST 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 Key10179803
MDR Text Key196548795
Report Number1625425-2020-00363
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K972262
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 06/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2021
Device Model Number384221
Device Catalogue Number384221
Device Lot Number11244858
Was Device Available for Evaluation? No
Date Returned to Manufacturer06/08/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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