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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA¿ 3 ML RETRACTING SAFETY SYRINGE; ANTISTICK SYRINGE
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BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA¿ 3 ML RETRACTING SAFETY SYRINGE; ANTISTICK SYRINGE Back to Search Results
Model Number 305270
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/22/2023
Event Type  malfunction  
Event Description
It was reported that the bd integra¿ 3 ml retracting safety syringe leaked.The following information was provided by the initial reporter: the product is leaking, when you draw up vaccine, the product will leak through the back where the plunger is.
 
Manufacturer Narrative
Date of event is unknown; awareness date 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 integra¿ 3 ml retracting safety syringe leaked.The following information was provided by the initial reporter: the product is leaking, when you draw up vaccine, the product will leak through the back where the plunger is.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval: yes.D10: returned to manufacturer on: 20-mar-2023.H6: investigation summary: one sample was provided to our quality team for investigation.The reported issue was not confirmed upon inspection of the samples.Since the reported defect was not confirmed a manufacturing root cause could not be determined.A device history record review was completed for provided lot number 1106180.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.
 
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Brand Name
BD INTEGRA¿ 3 ML RETRACTING SAFETY SYRINGE
Type of Device
ANTISTICK 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
8448235433
MDR Report Key16549514
MDR Text Key311603273
Report Number1213809-2023-00204
Device Sequence Number1
Product Code MEG
UDI-Device Identifier30382903052708
UDI-Public(01)30382903052708
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011103
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/23/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number305270
Device Catalogue Number305270
Device Lot Number1106180
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/22/2023
Initial Date FDA Received03/15/2023
Supplement Dates Manufacturer Received03/23/2023
Supplement Dates FDA Received04/02/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/16/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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