FDA Adverse Event Malfunction Summary report: N

L-CATH PICC S/L 28GA (1.2F) X 25CM 1 LUMEN)

MDR report key: 12537532 · Received September 27, 2021

Report

Report Number: 0001625425-2021-01087
Event Type: Malfunction
Date Received: September 27, 2021
Date of Event: August 28, 2021
Report Date: October 20, 2021
Product Code: FOZ
UDI-DI: 00886333209910
PMA / PMN Number: K091670
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

ONE CATHETER WAS RETURNED FOR REVIEW. VISUAL INSPECTION CONFIRMED A CRACK OPPOSITE THE GATE OF THE FEMALE LUER THAT 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.

Additional Manufacturer Narrative · 0

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 · 0

CRACKED PICC - LEAKING NOTICED UNDER THE DRESSING WHERE THE GLUE WAS STUCK TO THE CATHETER. 1.2 FR PICC L-CATH (ARGON) CAT# 095-384516 LOT# 11351102 INSERTED ON AUG 18, 2021 DEVICE WAS REMOVED AND A NEW ONE NEEDED TO BE PLACED.

Description of Event or Problem · 0

CRACKED PICC - LEAKING NOTICED UNDER THE DRESSING WHERE THE GLUE WAS STUCK TO THE CATHETER. 1.2 FR PICC L-CATH (ARGON) CAT# 095-384516 LOT# 11351102 INSERTED ON (B)(6) 2021 DEVICE WAS REMOVED AND A NEW ONE NEEDED TO BE PLACED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1435497	L-CATH PICC S/L 28GA (1.2F) X 25CM 1 LUMEN)	L-CATH PICC	FOZ		384516	11351102	00886333209910

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other