SMITHS MEDICAL CENTRAL VENOUS CATHETERS
Received Nov 25, 2019 · Event occurred Oct 30, 2019
Report 3012307300-2019-06793 · MDR key 9371916
Device
Generic name
Central Venous Catheter Tray
Manufacturer
Smiths Medical Asd, Inc.Catalog number
MXA232X20X70-NIT
Lot number
3819285
Product problems
- Output Problem
- Output Problem
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
DEVICE WAS NOT RECEIVED FOR EVALUATION. HOWEVER, ONE PHOTO WAS PROVIDED, AND VISUAL INSPECTION REVEALED THE ARTICLE, LOT NUMBER AND MANUFACTURING AND EXPIRY DATES WERE MISSING ON THE LABEL. THE REPORTED CUSTOMER COMPLAINT HAS BEEN CONFIRMED. BASED ON THIS REVIEW, THE PROBLEM SOURCE HAS BEEN DETERMINED TO BE MANUFACTURING.
Description of Event or Problem
INFORMATION WAS RECEIVED THAT CENTRAL VENOUS CATHETER WAS NOTED TO BE RECEIVED WITHOUT THE ORIGINAL MANUFACTURER'S LABEL. INCIDENT OCCURRED PRIOR TO USE WITH A PATIENT.