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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL INTERNATIONAL, LTD. SODASORB CANISTER BOTTLE, COLLECTION AND TRAP, BREATHING SYSTEM Back to Search Results
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.
 
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Brand NameSODASORB CANISTER
Type of DeviceBOTTLE, COLLECTION AND TRAP, BREATHING SYSTEM
Manufacturer (Section D)
SMITHS MEDICAL INTERNATIONAL, LTD.
boundary road
hythe, kent CT21 6JL
UK CT21 6JL
Manufacturer (Section G)
SMITHS MEDICAL INTERNATIONAL, LTD.
boundary road
hythe, kent CT216 JL
UK CT216JL
Manufacturer Contact
david halverson
6000 nathan lane north,
minneapolis, MN 55442
MDR Report Key10552764
MDR Text Key208300560
Report Number3012307300-2020-09487
Device Sequence Number1
Product Code CBC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number008870
Device Catalogue Number008870
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/14/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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