MAUDE Adverse Event Report: ARGON MEDICAL DEVICES 1ST PICC

Catalog Number UNKNOWN

Device Problem Break (1069)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 04/23/2016

Event Type  malfunction  

Manufacturer Narrative

As the product was not returned, and an incorrect lot number was provided, no definitive root cause could be established for this issue.Catheter breakage can be related to securement techniques and catheter maintenance techniques.The instructions for use include many ways users can mitigate the occurrence of breakage, including instructions not to flush the catheter with excess force and instructions not to tape over the catheter tubing.

Event Description

Catheter picc broke during medication; was necessary to pass new catheter causing damage to the newborn.

• Brand Name: 1ST PICC
• Type of Device: 1ST PICC
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek road; athens TX 75751
• Manufacturer (Section G): ARGON MEDICAL DEVICES
• Manufacturer Contact: gail smith ; 1445 flat creek road; athens, TX 75751 ; 2144368995
• MDR Report Key: 5892698
• MDR Text Key: 52620960
• Report Number: 1625425-2016-00044
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/25/2016
• Initial Date FDA Received: 08/21/2016
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention