MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. SODASORB CANISTER; BOTTLE, COLLECTION AND TRAP, BREATHING SYSTEM

Model Number 008870

Device Problem Shipping Damage or Problem (1570)

Patient Problem Chills (2191)

Event Type  malfunction  

Event Description

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.

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.

• Brand Name: SODASORB CANISTER
• Type of Device: BOTTLE, COLLECTION AND TRAP, BREATHING SYSTEM
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• MDR Report Key: 10552764
• MDR Text Key: 208300560
• Report Number: 3012307300-2020-09487
• Device Sequence Number: 1
• Product Code: CBC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 008870
• Device Catalogue Number: 008870
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1