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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE LUER-LOK¿ TIP; PISTON SYRINGE
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BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE LUER-LOK¿ TIP; PISTON SYRINGE Back to Search Results
Model Number 300912
Device Problem Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/18/2022
Event Type  malfunction  
Event Description
It was reported that the bd syringe luer-lok¿ tip was being used on a picc and whilst in use the syringe shattered part of which hit the patient.The following information was provided by the initial reporter, bung came off plunger.
 
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
H6: investigation summary: one sample and two photos were provided to our quality team for investigation.Through visual inspection, it was observed that the stopper is not connected to the crown of the plunger rod.The condition observed is non-conforming per product specification.Potential root cause for insecure stopper defect is associated with the assembly process.A device history record review was completed for provided lot number 1158040.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 the bd syringe luer-lok¿ tip was being used on a picc and whilst in use the syringe shattered part of which hit the patient.The following information was provided by the initial reporter, bung came off plunger.
 
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Brand Name
BD SYRINGE LUER-LOK¿ TIP
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 Key15229507
MDR Text Key304836736
Report Number1213809-2022-00494
Device Sequence Number1
Product Code FMF
UDI-Device Identifier30382903009122
UDI-Public30382903009122
Combination Product (y/n)N
Reporter Country CodeNZ
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 08/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number300912
Device Catalogue Number300912
Device Lot Number1158040
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/08/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/22/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/07/2021
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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