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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD SAFETYGLIDE 1 ML SYRINGE SYRINGE, PISTON

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BECTON, DICKINSON AND COMPANY BD SAFETYGLIDE 1 ML SYRINGE SYRINGE, PISTON Back to Search Results
Model Number 305945
Device Problems Detachment Of Device Component (1104); Component Falling (1105)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/11/2018
Event Type  malfunction  
Event Description
Nurse attempted to raise white lever to cover needle (safety mechanism) and the entire needle assembly flew off the syringe and landed on the floor without the needle being covered.
 
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Brand NameBD SAFETYGLIDE 1 ML SYRINGE
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY
1 becton drive
franlkin lakes NJ 07417 6800
MDR Report Key7288862
MDR Text Key100681132
Report Number7288862
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 01/12/2018,02/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number305945
Device Catalogue Number305945
Other Device ID Number0100382903059454
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/12/2018
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer01/12/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/22/2018 Patient Sequence Number: 1
Treatment
NOT KNOWN.
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