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

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).

• Brand Name: FIRST PICC 26GA, SINGLE LUMEN
• Type of Device: FIRST 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 Key: 7064566
• MDR Text Key: 93865499
• Report Number: 1625425-2017-00155
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972262
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Nurse
• 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 Received: 11/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2020
• Device Catalogue Number: 384232
• Device Lot Number: 11184377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other