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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; ANTI-STICK SYRINGE

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BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA¿ 3 ML RETRACTING SAFETY SYRINGE; ANTI-STICK SYRINGE Back to Search Results
Model Number 305270
Device Problems Complete Blockage (1094); Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/06/2023
Event Type  malfunction  
Event Description
It was reported while using bd integra¿ 3 ml retracting safety syringe there was a crack and leakage occurred.This occurred twice.There was no report of patient impact.The following information was provided by the initial reporter: when injecting the vaccine, the contents of the syringe came out of the luer lock area and ran down the patient's arm.This happened twice.Also had found syringes with cracks in the area of the luer lock.
 
Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Manufacturer Narrative
H6: investigation summary since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.H3 other text : see h10.
 
Event Description
It was reported while using bd integra¿ 3 ml retracting safety syringe there was a crack and leakage occurred.This occurred twice.There was no report of patient impact.The following information was provided by the initial reporter: when injecting the vaccine, the contents of the syringe came out of the luer lock area and ran down the patient's arm.This happened twice.Also had found syringes with cracks in the area of the luer lock.
 
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Brand Name
BD INTEGRA¿ 3 ML RETRACTING SAFETY SYRINGE
Type of Device
ANTI-STICK 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 Key16475808
MDR Text Key310632498
Report Number1213809-2023-00140
Device Sequence Number1
Product Code MEG
UDI-Device Identifier30382903052708
UDI-Public(01)30382903052708
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K011103
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 03/10/2023
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 Number9294200
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/06/2023
Initial Date FDA Received03/02/2023
Supplement Dates Manufacturer Received03/10/2023
Supplement Dates FDA Received03/23/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/21/2019
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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