FDA Adverse Event Malfunction Summary report: N

SURESTEP FOLEY TRAY SYSTEM BARD LUBRI-SIL FOLEY CATHETER TRAY

MDR report key: 8623360 · Received May 20, 2019

Report

Report Number
8623360
Event Type
Malfunction
Date Received
May 20, 2019
Date of Event
April 18, 2019
Report Date
April 23, 2019
Manufacturer
C. R. BARD, INC.
Product Code
EZL
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MN
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

CATHETER KIT MISSING STERILE GLOVES AND ONE STERILE SWAB.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
416671 SURESTEP FOLEY TRAY SYSTEM BARD LUBRI-SIL FOLEY CATHETER TRAY CATHETER, RETENTION TYPE, BALLOON EZL C. R. BARD, INC. A942216 NGCX1532

Patients

Seq Age Sex Outcome Treatment
1