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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. FIRST PICC¿ S/L PERIPHERALLY INSERTED CENTRAL CATHETER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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ARGON MEDICAL DEVICES, INC. FIRST PICC¿ S/L PERIPHERALLY INSERTED CENTRAL CATHETER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 384232
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/15/2018
Event Type  malfunction  
Event Description
Bedside rn went to bedside to do their hourly picc line check.She had visualized the line previously, 2 hours earlier, and it was normal.During this check, she found the picc line lying in bed bedside the baby.The line had snapped at the side of the heart closest to the baby.The remaining portion of the line was still secured to the baby's arm by the picc dressing.
 
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Brand Name
FIRST PICC¿ S/L PERIPHERALLY INSERTED CENTRAL CATHETER
Type of Device
CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
ARGON MEDICAL DEVICES, INC.
1445 flat creek rd
athens TX 75751
MDR Report Key7432444
MDR Text Key105539857
Report Number7432444
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00886333209750
UDI-Public(01)00886333209750
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number384232
Device Catalogue Number384232
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/30/2018
Event Location Hospital
Date Report to Manufacturer03/30/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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