MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. FIRST PICC S/L PERIPHERALLY INSERTED CENTRAL CATHETER

Catalog Number 384232

Device Problem Fracture (1260)

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

Event Date 12/23/2019

Event Type  malfunction  

Manufacturer Narrative

Argon medical has requested the return of the sample device from the complainant for evaluation.A follow-up report with additional information will be provided by 2/14/2020.

Event Description

Picc was placed on (b)(6) 2019.Multiple repositioning and x rays were done before it went into appropriate central position.Infant had been to surgery for a procedure, upon return a routine x ray was performed.Radiologist noted a possible fracture in picc line.Infant was taken to interventional radiology to have line removed over a wire under fluoroscopy.Entire length was removed at this time.The fracture in the line was able to be seen.Hub end of picc was cut off in interventional radiology so wire could be threaded.Fracture point was at distal end -2 cm from the tic of catheter.

• Brand Name: FIRST PICC S/L PERIPHERALLY INSERTED CENTRAL CATHETER
• 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: 9597469
• MDR Text Key: 189334902
• Report Number: 1625425-2020-00068
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/01/2005,12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/18/2022
• Device Catalogue Number: 384232
• Device Lot Number: 11267948
• Was Device Available for Evaluation?: Yes
• 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: 12/23/2019
• 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
• Patient Sequence Number: 1