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

Catalog Number 384221

Device Problems Material Rupture (1546); Physical Resistance (2578)

Patient Problem No Information (3190)

Event Date 12/04/2016

Event Type  malfunction  

Manufacturer Narrative

A review of the device history records and inspection records was conducted and no similar concerns were found.This complaint could not be confirmed because no product was returned for evaluation.Catheter damage, such as rupture, can be related to handling in the user environment.Some potential contributors to catheter damage can include removing the stylet despite resistance, taping over the catheter tubing, or excess tension (which can be applied due to improper handling/securement techniques).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 presenting resistance, but nonpermanent.When performing salination with a suitable 10 ml syringe, without forcing or pressing, it ruptured near the cannon.Infusion under constant flow of +/- 2ml/h.

Manufacturer Narrative

A review of the device history records and inspection records was conducted and no similar concerns were found.The returned catheter was evaluated and a slit was found along the overmolded extension set of the catheter.The catheter was flushed using a syringe and it leaked at this location.Catheter damage, such as rupture, can be related to handling in the user environment.Some potential contributors to catheter damage can include removing the stylet despite resistance, taping over the catheter tubing, or excess tension (which can be applied due to improper handling/securement techniques).Another potential cause is that the catheter may have been cut inadvertently in the user environment.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.

• Brand Name: FIRST PICC 26GA, SINGLE LUMEN, BASIC KIT
• 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: 6311617
• MDR Text Key: 67221123
• Report Number: 1625425-2017-00010
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K972262
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2018
• Device Catalogue Number: 384221
• Device Lot Number: 11135595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2016
• 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