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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE CONTROL 10ML LL PISTON SYRINGE

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BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE CONTROL 10ML LL PISTON SYRINGE Back to Search Results
Model Number 309695
Device Problem Leak/Splash (1354)
Patient Problem Needle Stick/Puncture (2462)
Event Date 12/01/2021
Event Type  malfunction  
Event Description
It was reported that at least one bd syringe control 10ml ll experienced a damaged plunger rod. The following information was provided by the initial reporter: the doctor was injecting local into the patient and as he was doing so the top ring of the control syringe slide off and snapped a part of the plunger, resulting in the syringe slipping and the needle sticking the dr. The nurse brought the syringe to me and explained that this particular issue has occurred several other times in the or, none resulting in injury.
 
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.
 
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Brand NameBD SYRINGE CONTROL 10ML LL
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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13101679
MDR Text Key285365883
Report Number1213809-2021-00824
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/28/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number309695
Device Catalogue Number309695
Device Lot NumberSEE H10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/13/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/27/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/26/2021
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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