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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE INTEGRA 3ML W/NDL 23X1 RB; PISTON SYRINGE
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BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE INTEGRA 3ML W/NDL 23X1 RB; PISTON SYRINGE Back to Search Results
Model Number 305271
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/21/2022
Event Type  malfunction  
Event Description
It was reported that the bd syringe integra 3ml w/ndl 23x1 rb experienced a collapse of the plunger rod.The following information was provided by the initial reporter: syringe broke in pieces; stated, a "spring" popped out of the barrel.
 
Manufacturer Narrative
A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
H.6.Investigation summary: in response to the event reported by the facility a device history review was conducted for lot number 0325703.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.Please note that this product has a retractable needle design.The metal cannula of the needle retracts into the inner plunger rod for safety.Since no samples displaying the reported condition were received a potential root cause could not be defined and corrective actions are not necessary.
 
Event Description
It was reported that the bd syringe integra 3ml w/ndl 23x1 rb experienced a collapse of the plunger rod.The following information was provided by the initial reporter: syringe broke in pieces; stated, a "spring" popped out of the barrel.
 
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Brand Name
BD SYRINGE INTEGRA 3ML W/NDL 23X1 RB
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 Key15236357
MDR Text Key305279868
Report Number1213809-2022-00500
Device Sequence Number1
Product Code MEG
UDI-Device Identifier30382903052715
UDI-Public30382903052715
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011103
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 08/29/2022
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 Lay User/Patient
Device Model Number305271
Device Catalogue Number305271
Device Lot Number0325703
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/21/2022
Initial Date FDA Received08/16/2022
Supplement Dates Manufacturer Received08/29/2022
Supplement Dates FDA Received09/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/20/2020
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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