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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 10/25/2017
Event Type  malfunction  
Manufacturer Narrative
One 26 ga catheter was returned. The tubing had separated just below the inverted triangle portion of the overmolded extension set. A jagged edge was observed at the area of separation. Potential causes for catheter breakage is the application of excess tensile (pulling) force to the catheter. Such excess force can be related to catheter securement techniques, improper maintenance, or advancing/removing the catheter or stylet despite resistance. Additionally, the application of excess pressure can weaken the catheter tubing. This can happen as a result of flushing the catheter with excess force (e. G. Using a syringe smaller than 10 ml, flushing the catheter despite experiencing resistance, flushing the catheter using a 10 ml syringe with excess pressure, etc. ). 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
Customer reports that the first picc 26g catheter snapped at the hub when a mother was holding baby on (b)(6).
 
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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 Key7064566
MDR Text Key93865499
Report Number1625425-2017-00155
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 11/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/07/2020
Device Catalogue Number384232
Device Lot Number11184377
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/06/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/30/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/07/2017
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: 11/28/2017 Patient Sequence Number: 1
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