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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. FIRST PICC 26GA, SINGLE LUMEN

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ARGON MEDICAL DEVICES INC. FIRST PICC 26GA, SINGLE LUMEN Back to Search Results
Catalog Number 384232
Device Problem Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/17/2017
Event Type  malfunction  
Manufacturer Narrative
One catheter was returned. An injector cap was attached to the luer adapter, which was not fully seated in the overmolded extension of the catheter. There was a gap of a few millimeters. The luer adapter was removed. The posts had broken off of the luer adapter. A definitive root cause for this complaint could not be determined. However, based on the fact that the posts had broken off the luer adapter, it is possible that the detachment was caused by the application of undue force to the luer adapter during the attempted removal of the injector cap. First picc catheters are 100% in-process inspected at various times during manufacture. Catheters are also leak and flow tested to ensure their integrity. Additionally, the instructions for use indicate several ways users can mitigate the occurrence of catheter damage.
 
Event Description
The bedside nurse was changing the injector cap attached to the hub of the picc. The hub became detached from the picc during this injection cap change. The nurse put the hub back into picc and notified nnp. Nnp will exchange this picc. No harm to patient.
 
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Brand NameFIRST PICC 26GA, 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 Key6644031
MDR Text Key77789248
Report Number1625425-2017-00080
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K972262
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 06/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number384232
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/31/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/17/2017
Was Device Evaluated by Manufacturer? Yes
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: 06/15/2017 Patient Sequence Number: 1
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