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

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.

• Brand Name: FIRST PICC 22GA, 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: 7216532
• MDR Text Key: 98422444
• Report Number: 1625425-2017-00211
• 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
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2020
• Device Catalogue Number: 384101
• Device Lot Number: 11171532
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2017
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention