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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ TIP DISPOSABLE SYRINGE; PISTON SYRINGE
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BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ TIP DISPOSABLE SYRINGE; PISTON SYRINGE Back to Search Results
Model Number 309657
Device Problems Break (1069); Material Too Soft/Flexible (4007)
Patient Problem Needle Stick/Puncture (2462)
Event Date 10/26/2021
Event Type  malfunction  
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 3 bd luer-lok¿ tip disposable syringes' plungers bent easily during use, and some broke.The following information was provided by the initial reporter: "she mentioned that the plunger bends and sometimes snaps.".
 
Manufacturer Narrative
H.6.Investigation: one box containing one-hundred and eighty-nine 3ml syringes (p/n 309657) sealed in blisterpaks from batch #1181532 were received.The samples were visually evaluated.No visual defects were observed.It should be noted that there was no plunger rod abnormalities present that would lead to the complaint defect.It is unclear in what way the syringe was being used that may have led to the plunger rod snapping as the customer reported.Since the samples did not display the reported condition a potential root cause could not be defined and corrective actions are not necessary.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.
 
Event Description
It was reported that 3 bd luer-lok¿ tip disposable syringes' plungers bent easily during use, and some broke.The following information was provided by the initial reporter: "she mentioned that the plunger bends and sometimes snaps.".
 
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Brand Name
BD LUER-LOK¿ TIP DISPOSABLE 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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12860910
MDR Text Key281164209
Report Number1213809-2021-00779
Device Sequence Number1
Product Code FMF
UDI-Device Identifier30382903096573
UDI-Public30382903096573
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110771
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 12/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number309657
Device Catalogue Number309657
Device Lot Number1181532
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/18/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/30/2021
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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