MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. PERIPHERALLY INSERTED CENTRAL CATHETER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Lot Number 11295808

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 05/30/2020

Event Type  malfunction  

Event Description

Performing our daily picc rounds assessment.Once at the bedside i noticed slight lifting around the left hand finger and thumb of the picc dressing.Upon closer examination it looked as if the catheter was loosely moving around and the steri strips underneath were slightly damp with sanguineous fluid.Although i could not feel any physical fluid at the time i attempted to reinforce the dressing until i was able to gather dressing change equipment at the bedside.Upon return and removal of the previous dressing i could then see that there was a significant amount of sanguineous fluid underneath the dressing and that the external catheter length (which was 2 cm from the hub to the spot that had snapped, the previous dressing note had stated that there should be 2.5cm external) was separated from the internal catheter length (a total catheter length of 22cm).I immediately put pressure on the forearm/area that i believed to be the insertion site and called nnp to the bedside.The catheter had snapped and immediately called surgery for consultation.After surgical intervention/removal the external length and internal length of catheter was saved for further inspection.

• Brand Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC.; 1445 flat creek rd.; athens TX 75751
• MDR Report Key: 10312081
• MDR Text Key: 199994789
• Report Number: 10312081
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 11295808
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/10/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/23/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other