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

Catalog Number 384232

Device Problems Break (1069); Fracture (1260)

Patient Problem Impaired Healing (2378)

Event Date 08/16/2019

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation and no images or videos have been provided, so the complaint cannot be confirmed.If additional information is provided in the future, this issue will be reevaluated as needed.

Event Description

A 1.9 fr argon peripherally inserted central catheter was placed in the right bronchial vein.During reassign for attachment of the line, the line broke 2 cm from the hub.The line was secured outside the vein and then really retracted from the vein upon comparing insertion length and removed length it was noted the line was 2 cm short and x-ray was taken and confirmed a segment of fractured line remained in the patient's arm just above the elbow.Pediatric surgery dissected through subcutaneous tissue and retrieved the fractured line.The infant tolerated the procedure without difficulty.Blood cultures drawn after the line fracture were negative x 72 hours and consequent antibiotics have been discontinued.The incision site is healing with difficulty and the infant is progressing in care.

• 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: 9185937
• MDR Text Key: 169238256
• Report Number: 1625425-2019-00267
• Device Sequence Number: 1
• 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: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/01/2005,09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2022
• Device Catalogue Number: 384232
• Device Lot Number: 11251353
• Was Device Available for Evaluation?: No
• 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
• Initial Date Manufacturer Received: 09/17/2019
• Initial Date FDA Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention