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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
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/23/2021
Type of Reportable Event Malfunction
Event or Problem Description
"4 (four) technical complaints were notified involving the following hospital material: first picc basic kit neonatal" defective puncture needle ((b)(6)).
 
Additional 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.
 
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Brand Name
FIRST PICC S/L 26GA (1.9F) X 50CM 1 LUMEN
Common Device Name
FIRST PICC
Manufacturer (Section D)
ARGON MEDICAL DEVICES
1445 flat creek rd
athens TX 75751
Manufacturer Contact
elnaz rahman
1445 flat creek rd
athens, TX 75751
9036759321
MDR Report Key13018458
Report Number0001625425-2021-01223
Device Sequence Number4872780
Product Code FOZ
UDI-Device Identifier00886333209743
UDI-Public00886333209743
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
K972262
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source Other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 12/16/2021
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
Operator of Device Health Professional
Device Model Number384221
Device Catalogue Number384221
Device Lot Number11327455
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/03/2021
Initial Report FDA Received Date12/16/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient SexUnknown
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