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

Catalog Number 384232

Device Problem Detachment Of Device Component (1104)

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

Event Date 05/17/2017

Event Type  malfunction  

Manufacturer Narrative

One catheter was returned.An injector cap was attached to the luer adapter, which was not fully seated in the overmolded extension of the catheter.There was a gap of a few millimeters.The luer adapter was removed.The posts had broken off of the luer adapter.A definitive root cause for this complaint could not be determined.However, based on the fact that the posts had broken off the luer adapter, it is possible that the detachment was caused by the application of undue force to the luer adapter during the attempted removal of the injector cap.First picc catheters are 100% in-process inspected at various times during manufacture.Catheters are also leak and flow tested to ensure their integrity.Additionally, the instructions for use indicate several ways users can mitigate the occurrence of catheter damage.

Event Description

The bedside nurse was changing the injector cap attached to the hub of the picc.The hub became detached from the picc during this injection cap change.The nurse put the hub back into picc and notified nnp.Nnp will exchange this picc.No harm to patient.

• 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: 6644031
• MDR Text Key: 77789248
• Report Number: 1625425-2017-00080
• 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,distri
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 384232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other