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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; CESAREAN SECTION TRAY
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CARDINAL HEALTH 200, LLC CARDINAL HEALTH; CESAREAN SECTION TRAY Back to Search Results
Model Number SMA12SEMWV
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/09/2019
Event Type  malfunction  
Event Description
This is a follow up to a previously reported issue.Earlier this summer, it was noted during a c section case that the tip of the yankauer suction from the kit was broken off.Since that time, there have been an additional 5 yankauer suction from c/s kits that have had the tips broken.Of these 5, only 1 was used on a patient (unknown).4 were discovered during set up and the last was not noted until it had been used on a patient.All involved devices have been from same lot #.To date, there have been no known injuries as a result of these broken devices.The manufacturer is aware and is actively investigating the issue.
 
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Brand Name
CARDINAL HEALTH
Type of Device
CESAREAN SECTION TRAY
Manufacturer (Section D)
CARDINAL HEALTH 200, LLC
785 fort mill hwy
fort mill SC 29707
MDR Report Key9218297
MDR Text Key163190888
Report Number9218297
Device Sequence Number1
Product Code OHM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 10/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberSMA12SEMWV
Device Catalogue NumberSMA12SEMWV
Device Lot Number538312
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/07/2019
Event Location Hospital
Date Report to Manufacturer10/22/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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