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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 Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/26/2022
Event Type  malfunction  
Manufacturer Narrative
The sample is indicated as available for return. As of the date of this report, the sample has not been returned. A follow-up report will be provided once the device has been received and reviewed.
 
Event Description
The customer said, ¿we had a picc line with multiple holes in the thicker part of the line proximal to the securement disc. /the line was leaking and was removed from the patient. ¿ the location of the holes is in between the disc and the connector.
 
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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
elnaz rahman
1445 flat creek rd
athens, TX 75751
9036759321
MDR Report Key13767486
MDR Text Key291633466
Report Number0001625425-2022-00960
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00886333209750
UDI-Public00886333209750
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 Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number384232
Device Catalogue Number384232
Device Lot Number11371220
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/01/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/15/2022 Patient Sequence Number: 1
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