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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. FIRST PICC S/L 26GA (1.9F) 0.65MM X 50 CM PICC LINE

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ARGON MEDICAL DEVICES, INC. FIRST PICC S/L 26GA (1.9F) 0.65MM X 50 CM PICC LINE Back to Search Results
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/03/2021
Event Type  Injury  
Event Description
The picc was being lifted as infant was being placed on top of a blanket for swaddling. The picc line broke at the sterile-strip chevron. The nurse applied pressure. A physician removed the line. There was no harm to the pt. The broken device was dis-guarded. The dressing was recently changed and the line was not secure. The dressing was not positioned properly.
 
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Brand NameFIRST PICC S/L 26GA (1.9F) 0.65MM X 50 CM
Type of DevicePICC LINE
Manufacturer (Section D)
ARGON MEDICAL DEVICES, INC.
athens TX 75751
MDR Report Key12204108
MDR Text Key262949679
Report Number12204108
Device Sequence Number1
Product Code FOZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 07/07/2021,07/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/07/2021
Distributor Facility Aware Date07/06/2021
Event Location Hospital
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 07/10/2021 Patient Sequence Number: 1
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