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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 Flushing Problem (1252); Material Puncture/Hole (1504)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/19/2020
Event Type  malfunction  
Manufacturer Narrative
The sample has been returned for evaluation.The investigation is ongoing.A follow-up report will be provided once the investigation has been completed.
 
Event Description
Tech attempted to flush with saline.Tech notified this rn that the line was not flushing.This rn went and examined, noticed there was blood coming from the rubber part of the line.This rn told the mri tech to grab sterile gauze and this rn applied pressure.Charge rn called to bedside.Infant brought back to nicu, picc line pulled by charge rn.Examination of line showed hole in rubber part of line.Line kept for further evaluation.
 
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 Key10157495
MDR Text Key196392142
Report Number1625425-2020-00353
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 06/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number384232
Device Catalogue Number384232
Was Device Available for Evaluation? No
Date Returned to Manufacturer06/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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