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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD 5ML SYRINGE LUER-LOK¿ TIP PISTON SYRINGE

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BECTON DICKINSON MEDICAL SYSTEMS BD 5ML SYRINGE LUER-LOK¿ TIP PISTON SYRINGE Back to Search Results
Model Number 309649
Device Problem Leak/Splash (1354)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Two photos showing 5ml syringes in bags (p/n 309649). In one photo it was observed that a label had been placed on the syringe and the tip had been capped. Approximately 1ml of an unknown medication was also present in the syringe it was unclear in this photo if any leakage was occurring. Another photo displayed an identical scenario to the first photo except it appeared that medication had leaked past the back rib of the stopper which is a non-conforming condition per product specification. A physical sample that clearly displays the defect is required for a more thorough evaluation, leakage testing, and potential root cause determination. Since root cause could not be defined, corrective actions are not necessary at this time. Furthermore, 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. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that the bd 5ml syringe luer-lok¿ tip experienced leakage past the plunger. The following information was provided by the initial reporter: we¿ve recently had a couple of syringes that have leaked from the black bung at the bottom of the syringe as the drug was administered and the plunger pushed into the barrel.
 
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Brand NameBD 5ML SYRINGE LUER-LOK¿ TIP
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 Key13101728
MDR Text Key285365710
Report Number1213809-2021-00826
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K110771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/13/2022
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 Number309649
Device Catalogue Number309649
Device Lot Number0213251
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/31/2020
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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