MAUDE Adverse Event Report: ARGON MEDICAL DEVICES FIRST PICC SILICONE SINGLE LUMEN 26GA (1.9F) X 50 CM

Model Number 384221

Device Problem Fracture (1260)

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

Event Date 06/01/2020

Event Type  malfunction  

Manufacturer Narrative

The sample was returned for evaluation. The investigation is ongoing. A follow-up report will be provided once the investigation is complete.

Event Description

Doctor noticed fracture of the catheter at the junction of the hub and catheter during post picc insertion. The catheter was used for i. V drip while waiting for tpn.

• Brand Name: FIRST PICC SILICONE SINGLE LUMEN 26GA (1.9F) X 50 CM
• Type of Device: FIRST PICC
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• Manufacturer Contact: gina liu ; 1445 flat creek rd, athens, tx 75751
• MDR Report Key: 10179803
• MDR Text Key: 196548795
• Report Number: 1625425-2020-00363
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K972262
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor

Reporter Occupation

• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/30/2021
• Device Model Number: 384221
• Device Catalogue Number: 384221
• Device Lot Number: 11244858
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/08/2020
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• 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: Unkown