FDA Adverse Event Malfunction Summary report: N

DUAL LUMEN L-CATH PICC CATHETER

MDR report key: 2080092 · Received April 6, 2011

Report

Report Number
1625425-2011-00038
Event Type
Malfunction
Date Received
April 6, 2011
Report Date
April 6, 2011
Manufacturer
ARGON MEDICAL DEVICES, INC.
Product Code
DQX
PMA / PMN Number
K925979
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
MA, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

RESULTS OF INVESTIGATION WILL BE FILED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem · 1

CATHETER BROKE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 DUAL LUMEN L-CATH PICC CATHETER DQX ARGON MEDICAL DEVICES, INC. NA 0214361

Patients

Seq Age Sex Outcome Treatment
1 UNK