SODASORB CANISTER
Received Sep 18, 2020
Report 3012307300-2020-09487 · MDR key 10552764
Device
Generic name
Bottle, Collection And Trap, Breathing System
Manufacturer
Smiths Medical International, Ltd.Model number
008870Catalog number
008870
Lot number
UNKNOWN
Product problems
- Device Damaged Prior to Receipt by User
- Device Damaged Prior to Receipt by User
Patient
Not reported
- Chills
- Chills
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RECEIVED ON 24-SEP-2020 AND FORWARDED TO THE SUPPLIER FOR INVESTIGATION. PER SUPPLIER RESPONSE IT HAS BEEN DETERMINED THAT THE DAMAGE OCCURS DURING SHIPMENTS OF SINGLE CARTONS OF PRE-PAKS® FROM THE DISTRIBUTORS TO END USERS. SMITHS MEDICAL HAS BEEN PROVIDED WITH SHIPPING PROCEDURES DETAILING PACKAGING THE SINGLE PACKS OF DISCS IN AN OVERPACK WITH SHIPPING POPCORN TO PREVENT DAMAGE TO THE DEVICE.
Description of Event or Problem
IT WAS REPORTED THAT TWO CASES OF SMITHS MEDICAL PREPAK CABISTERS CAME DAMAGED WHERE THE CANISTERS HAVE BEEN CRACKED AND THE SOLUTION IS LEAKING OUT. THERE WAS NO DAMAGE TO THE SHIPPING BOX. NO ADVERSE PATIENT EFFECTS WERE REPORTED.