MAUDE Adverse Event Report: ARGON MEDICAL DEVICES FIRST PICC S/L 26GA (1.9F) 0.65MM X 50CM

Model Number 384232

Device Problems Break (1069); Fluid/Blood Leak (1250); Fracture (1260)

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

Event Date 05/20/2020

Event Type  malfunction  

Manufacturer Narrative

The device is indicated as available for evaluation.Argon has made three requests for the return of the device and as of the date of this report, it has not yet be returned.Without the sample or any visual evidence, the complaint cannot be confirmed.If additional information is received in the future, a follow-up report will be provided.

Event Description

Per the med watch report ¿while attempting a picc insertion, rn threaded catheter trough introducer into vessel and the line would draw and flush without difficulty.When attempted to advance catheter 2cm, catheter buckled under skin.Rn attempted to draw and flush line again and catheter then was leaking clear fluid out of the insertion site.When withdrawing the catheter out of the body, rn noted the catheter to be slightly fractured and then completely snapped in two parts when attempt was made to cut catheter segment for this report.All cm were accounted for 15 total, therefore no cm left inside body.¿.

Event Description

Follow up.

• Brand Name: FIRST PICC S/L 26GA (1.9F) 0.65MM X 50CM
• Type of Device: FIRST PICC
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• MDR Report Key: 10211894
• MDR Text Key: 197916330
• Report Number: 1625425-2020-00369
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00886333209750
• UDI-Public: 00886333209750
• Combination Product (y/n): N
• PMA/PMN Number: K972262
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2022
• Device Model Number: 384232
• Device Catalogue Number: 384232
• Device Lot Number: 11286356
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other