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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD TUBERCULIN SYRINGE WITH THE BD PRECISIONGLIDE DETACHABLE NEEDLE PISTON SYRINGE

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BECTON DICKINSON MEDICAL SYSTEMS BD TUBERCULIN SYRINGE WITH THE BD PRECISIONGLIDE DETACHABLE NEEDLE PISTON SYRINGE Back to Search Results
Model Number 309623
Device Problem Material Separation (1562)
Patient Problem Needle Stick/Puncture (2462)
Event Date 07/13/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. A device evaluation is anticipated but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that the bd precisionglide¿ detachable needle hub separated from the bd¿ tuberculin syringe. The following information was provided by the initial reporter: "needle hub separated from the syringe. ".
 
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Brand NameBD TUBERCULIN SYRINGE WITH THE BD PRECISIONGLIDE DETACHABLE NEEDLE
Type of DevicePISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer (Section G)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12303094
MDR Text Key265883021
Report Number1213809-2021-00555
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K980580
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number309623
Device Catalogue Number309623
Device Lot Number9106713
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/17/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/25/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/16/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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