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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ AMBER ORAL SYRINGE WITH NON LUER TIP; LIQUID MEDICATION DISPENSER
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BECTON DICKINSON MEDICAL SYSTEMS BD¿ AMBER ORAL SYRINGE WITH NON LUER TIP; LIQUID MEDICATION DISPENSER Back to Search Results
Catalog Number 305207
Device Problems Material Deformation (2976); Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/29/2022
Event Type  malfunction  
Manufacturer Narrative
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 8 bd¿ amber oral syringe with non luer tip experienced stopper defective.The following information was provided by the initial reporter: the customer states that they've had 8 complaints of the syringes being broken, i believe its the stopper getting stuck.
 
Manufacturer Narrative
H6: investigation summary: one photo was provided to our quality team for investigation.The jammed stopper condition was not observed in the photo.Since no samples displaying the reported condition were received a potential root cause could not be defined and corrective actions are not necessary.A device history record review was completed for provided lot number 1053334.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.
 
Event Description
It was reported that 8 bd¿ amber oral syringe with non luer tip experienced stopper defective.The following information was provided by the initial reporter: the customer states that they've had 8 complaints of the syringes being broken, i believe its the stopper getting stuck.
 
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Brand Name
BD¿ AMBER ORAL SYRINGE WITH NON LUER TIP
Type of Device
LIQUID MEDICATION DISPENSER
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 Key15171041
MDR Text Key302571917
Report Number1213809-2022-00450
Device Sequence Number1
Product Code KYW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
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 08/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number305207
Device Lot Number1053334
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/22/2021
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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