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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) X 50CM 1 LUMEN
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ARGON MEDICAL DEVICES FIRST PICC S/L 26GA (1.9F) X 50CM 1 LUMEN Back to Search Results
Model Number 384221
Device Problem Material Rupture (1546)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/05/2023
Event Type  malfunction  
Event Description
Reporter indicate catheter ruptured and had micro-holes.
 
Manufacturer Narrative
Sample is not available for return.The investigation is in progress.A follow-up report will be submitted upon investigation completion.
 
Manufacturer Narrative
A review of the dhr and inspection records could not be conducted since a lot number was not provided.According to the customer, there was no sample available for review.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.Without such evidence, the results are inconclusive and determining a definite root cause is not possible.If the samples are returned at a future date, this complaint may be reopened for further evaluation at that time.
 
Manufacturer Narrative
A review of the dhr and inspection records could not be conducted since a lot number was not provided.According to the customer, there was no sample available for review.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.Without such evidence, the results are inconclusive and determining a definite root cause is not possible.If the samples are returned at a future date, this complaint may be reopened for further evaluation at that time.
 
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Brand Name
FIRST PICC S/L 26GA (1.9F) X 50CM 1 LUMEN
Type of Device
FIRST PICC
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 Key18879513
MDR Text Key337436182
Report Number0001625425-2024-00962
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00886333209743
UDI-Public00886333209743
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K972262
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 03/11/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number384221
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/16/2024
Initial Date FDA Received03/11/2024
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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