MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. 1ST PICC S/L 26GA; FIRST PICC

Catalog Number 384232

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 01/04/2016

Event Type  malfunction  

Manufacturer Narrative

There was no patient injury.The picc broke and have to be taken out and replaced with an another picc.The dhrs were reviewed for lot 11114878 (packaging of the catheter into the kit),as well as for the catheter assembly lots.No similar concerns were found.One catheter was returned and breakage was confirmed below the nose of the over molding.The area of separation exhibited jagged edges.The cross-section of the tubing was complete and exhibited no noticeable inconsistencies.There are cautions and warnings in the ifu to mitigate picc breakage during insertion.Based on the analysis of the returned sample, it is possible that the breakage was due to the technique of the operator.

Event Description

Picc broke off at the point where the wing meets the catheter.They had to put in an additional picc line due to this occurrence.

• Brand Name: 1ST PICC S/L 26GA
• 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.; TX
• Manufacturer Contact: gail smith ; 1445 flat creek road; athens, TX 75751 ; 2144368995
• MDR Report Key: 5405671
• MDR Text Key: 37720499
• Report Number: 1625425-2015-00077
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 384232
• Device Lot Number: 11114878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2015
• 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