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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. FIRST PICC 22GA, SINGLE LUMEN

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ARGON MEDICAL DEVICES INC. FIRST PICC 22GA, SINGLE LUMEN Back to Search Results
Catalog Number 384101
Device Problem Hole In Material (1293)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/06/2017
Event Type  malfunction  
Manufacturer Narrative
A review of the device history records and inspection records was conducted and no similar concerns were found. At this time, a sample has not been returned for review. Without the sample to review, a definite root cause and corrective action cannot be established. First picc catheters are 100% in-process inspected at various times during manufacture. Catheters are also leak, flow, and burst tested to ensure their integrity. Additionally, the instructions for use indicate several ways users can prevent catheter damage.
 
Event Description
Catheter picc 22ga 2. 8fr blue was installed in the patient and when washed by the nursing team, presented a hole, in need of replacing the material.
 
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Brand NameFIRST PICC 22GA, SINGLE LUMEN
Type of DeviceFIRST PICC
Manufacturer (Section D)
ARGON MEDICAL DEVICES INC.
1445 flat creek road
athens TX 75751
Manufacturer (Section G)
ARGON MEDICAL DEVICES INC.
Manufacturer Contact
gail smith
1445 flat creek road
athens, TX 75751
2144368995
MDR Report Key7216532
MDR Text Key98422444
Report Number1625425-2017-00211
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K972262
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,user facility
Reporter Occupation
Type of Report Initial
Report Date 01/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/14/2020
Device Catalogue Number384101
Device Lot Number11171532
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/27/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/24/2018 Patient Sequence Number: 1
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