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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 Burst Container or Vessel (1074); Complete Blockage (1094); Coagulation in Device or Device Ingredient (1096); No Flow (2991)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/12/2020
Event Type  malfunction  
Manufacturer Narrative
The device is indicated as available for evaluation.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the sample has been received and reviewed.
 
Event Description
(b)(6): picc removed due to occlusion/clot.Inserted on (b)(6) 2020 in left arm.Lot # 11281136.Tpa was attempted but unsuccessful.Picc was removed successfully.When the picc was out, the arnp attempted to flush the line to see where the clot had formed.The picc line began to bubble up at the argon hub and then burst.(picc was not saved).
 
Manufacturer Narrative
H3 other text : placeholder.
 
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Brand Name
FIRST PICC S/L 26GA (1.9F) 0.65MM X 50CM
Type of Device
FIRST PICC
Manufacturer (Section D)
ARGON MEDICAL DEVICES
1445 flat creek rd
athens TX
MDR Report Key10121350
MDR Text Key194313283
Report Number1625425-2020-00343
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00886333209750
UDI-Public00886333209750
Combination Product (y/n)N
PMA/PMN Number
K972262
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Remedial Action Other
Type of Report Initial,Followup
Report Date 06/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/21/2022
Device Model Number384232
Device Catalogue NumberZ0384232AAL
Device Lot Number11281136
Was Device Available for Evaluation? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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