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

Catalog Number 384232

Device Problems Break (1069); Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/28/2018

Event Type  malfunction  

Manufacturer Narrative

A review of the device history records and inspection records was conducted, and no similar concerns were found.A review of returned product from the customer was performed.Visual inspection found that the picc tubing was broken at the hub, and the complaint was confirmed.The exact root cause is unable to be determined; however, possible causes may be related to patient activity/movement or excessive tensile/pulling force during use.All catheters undergo (100%) inspection during manufacturing.Catheters undergo tensile strength testing, flow, leak, and burst testing to ensure the integrity of the catheter, and its ability to endure use.

Event Description

Father of baby (fob) was holding infant when nurse noticed that the picc dressing was loose and picc was no longer secure.Nurse briefly secured line, put infant back to bed, obtained assistance, and attempted to change the dressing.At this time the picc broke at the hub.

• 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: 8381700
• MDR Text Key: 138574737
• Report Number: 1625425-2019-00035
• Device Sequence Number: 0
• Product Code: FOZ
• Combination Product (y/n): Y
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/01/2005,02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2021
• Device Catalogue Number: 384232
• Device Lot Number: 11220969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 02/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2018
• 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