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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ TIP SYRINGE; PISTON SYRINGE
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BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ TIP SYRINGE; PISTON SYRINGE Back to Search Results
Model Number 309628
Device Problems Leak/Splash (1354); Material Deformation (2976); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/25/2022
Event Type  malfunction  
Event Description
It was reported that the bd luer-lok¿ tip syringe plunger was deformed and the stopper was enlarged, causing eylea medication to leak past during use.The following information was provided by the initial reporter: "the reporter stated that the doctor determined the syringe to be defective right before it was to be administered.She specified that some medication flowed (leaked) past the stopper of the syringe during the priming of the dose.And added that the "stopper enlarged".Per reporter, physician drew up contents of vial into syringe and noticed that the plunger inside the syringe was crooked and "looked twisted." a separate eylea vial kit was used to administer the patient's scheduled dose.".
 
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 luer-lok¿ tip syringe plunger was deformed and the stopper was enlarged, causing eylea medication to leak past during use.The following information was provided by the initial reporter: "the reporter stated that the doctor determined the syringe to be defective right before it was to be administered.She specified that some medication flowed (leaked) past the stopper of the syringe during the priming of the dose.And added that the "stopper enlarged".Per reporter, physician drew up contents of vial into syringe and noticed that the plunger inside the syringe was crooked and "looked twisted." a separate eylea vial kit was used to administer the patient's scheduled dose.".
 
Manufacturer Narrative
H.6.Investigation: seven photos were received and evaluated.Photos showed a 1ml luer lock syringe (p/n 309628) with customer attached needle, the stopper appeared to be jammed and leakage was also observed with fluid past the ribs.No plunger defects were observed from photos.The observed conditions were non-conforming per product specification.Potential root cause for the jammed stopper and leakage past stopper defects are associated with the assembly process.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.
 
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Brand Name
BD LUER-LOK¿ TIP SYRINGE
Type of Device
PISTON 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 Key13472788
MDR Text Key285714850
Report Number1213809-2022-00051
Device Sequence Number1
Product Code FMF
UDI-Device Identifier30382903096283
UDI-Public30382903096283
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K941562
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 02/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2023
Device Model Number309628
Device Catalogue Number309628
Device Lot Number8277864
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/24/2018
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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