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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD BD SAFETYGLIDE; SAFETYGLIDE SYRINGE
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BD BD SAFETYGLIDE; SAFETYGLIDE SYRINGE Back to Search Results
Lot Number 4071210
Device Problems Decrease in Suction (1146); No Flow (2991)
Patient Problem No Information (3190)
Event Date 12/27/2014
Event Type  malfunction  
Event Description
When withdrawing the plunger on a bd safetyglide syringe the fluid did not get pulled into the syringe.There was no suction when withdrawing.The syringe was discarded and the subsequent syringe worked correctly.
 
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Brand Name
BD SAFETYGLIDE
Type of Device
SAFETYGLIDE SYRINGE
Manufacturer (Section D)
BD
5859 farinon dr ste 200
san antonio, TX 78249
MDR Report Key4515085
MDR Text Key16886733
Report Number4515085
Device Sequence Number1
Product Code FMF
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 01/06/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Invalid Data
Device Lot Number4071210
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/27/2015
Event Location Hospital
Date Report to Manufacturer02/13/2015
Is This a Reprocessed and Reused Single-Use Device? Yes
Patient Sequence Number1
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