L-CATH PICC D/L 20GA (2.6F) 0.90MM X 60CM

Report

Report Number: 0001625425-2021-01048
Event Type: Malfunction
Date Received: July 27, 2021
Date of Event: July 7, 2021
Report Date: September 23, 2021
Manufacturer: ARGON MEDICAL DEVICES
Product Code: LJS
PMA / PMN Number: K091670
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 0

A REVIEW OF THE RETURNED CATHETER FOUND A CRACKED HUB WHICH WOULD RESULT IN LEAKAGE, CONFIRMING THE COMPLAINT. CAPA C-2020-016 WAS PREVIOUSLY INITIATED TO ADDRESS THE PROBLEM, HOWEVER, THE CORRECTIVE ACTIONS IMPLEMENTED FAILED TO MITIGATE THE FAILURE. THE ROOT CAUSE INVESTIGATION HAS BEEN RE-OPENED WITH A NEW CAPA C-2021-039. THE CAPA WILL ALSO CAPTURE THE INITIATIVE TO IMPROVE THE PRODUCT DESIGN.

Description of Event or Problem · 0

2.6FR ARGON DL PICC PLACED BY INTERVENTIONAL RADIOLOGY ON (B)(6) 2021 IN RIGHT FEMORAL VEIN. CATHETER TRIMMED TO 16 CM WITH 0.5CM EXTERNAL LENGTH. ON (B)(6) 2021 AT 0600 CRACK FOUND ALONG BLUE HUB WHERE NEEDLESS CONNECTOR ATTACHES PICC REMOVED AND IV THERAPY COMPLETED AT THAT TIME.

Additional Manufacturer Narrative · 1

THE SAMPLE IS EXPECTED TO RETURN FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE SAMPLE HAS BEEN RECEIVED AND REVIEWED.

Description of Event or Problem · 1

2.6FR ARGON DL PICC PLACED BY INTERVENTIONAL RADIOLOGY ON (B)(6) 2021 IN RIGHT FEMORAL VEIN. CATHETER TRIMMED TO 16 CM WITH 0.5CM EXTERNAL LENGTH. ON (B)(6) 2021 AT 0600 CRACK FOUND ALONG BLUE HUB WHERE NEEDLESS CONNECTOR ATTACHES PICC REMOVED AND IV THERAPY COMPLETED AT THAT TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1123388	L-CATH PICC D/L 20GA (2.6F) 0.90MM X 60CM	L-CATH PICC	LJS	ARGON MEDICAL DEVICES	384466	11316041

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other