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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD LUER-LOK TIP 10-ML SYRINGE; PISTON SYRINGE

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BECTON DICKINSON DE MEXICO BD LUER-LOK TIP 10-ML SYRINGE; PISTON SYRINGE Back to Search Results
Model Number 309604
Device Problem Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/13/2023
Event Type  malfunction  
Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported while using bd luer-lok tip 10-ml syringe the stopper was misaligned.This occurred 3 times.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: the customer reported multiple defects, including fm (dirt), printing issues, and damaged components, in a total of 35 products.
 
Event Description
It was reported while using bd luer-lok tip 10-ml syringe the stopper was misaligned.This occurred (b)(4) times.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: the customer reported multiple defects, including fm (dirt), printing issues, and damaged components, in a total of (b)(4) products.
 
Manufacturer Narrative
H.6.Investigation summary: thirty five samples and photos received by our quality team for investigation.Through visual evaluation, foreign matter such as embedded particles, black dots, and ink stains observed on 12 syringes, 10 observed with incomplete marking scale, 6 with damaged barrel, jammed stopper on 3 syringes, and 4 with molding defect at the tip of syringe.A device history review was performed for lot 2045798, no deviations or non-conformances were identified during the manufacturing process that could have contributed to scale marking, damaged barrel, jammed stopper, and molding defect.Based on the quality teams investigation, the root cause for jammed stopper is misalignment of plunger-stopper-barrel in the assembly station, damaged barrel and molding defect is due to poor condition of conveyor belt, scale marking is due to ink level sensor, and foreign matter is embedded burnt material from molding process.This defect appeared due to the injection of burnt material generated during molding process.Before the injection machine is restarted up it is purged until the material is acceptable rejecting the first pieces.Injection machines are periodically subjected to maintenance and cleaning program.Manufacturing personnel have been notified and additional training to reinforce proper assembly has been performed.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.
 
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Brand Name
BD LUER-LOK TIP 10-ML SYRINGE
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON DE MEXICO
autopista
55 59 99 8400, k.m. 37.5
cuautitlan izcalli
Manufacturer (Section G)
BECTON DICKINSON DE MEXICO
autopista
55 59 99 8400, k.m. 37.5
cuautitlan izcalli
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8448235433
MDR Report Key16512988
MDR Text Key310983525
Report Number9614033-2023-00016
Device Sequence Number1
Product Code FMF
UDI-Device Identifier30382903096047
UDI-Public(01)30382903096047
Combination Product (y/n)N
Reporter Country CodeJA
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 08/14/2023
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 Other
Device Model Number309604
Device Catalogue Number309604
Device Lot Number2045798
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/21/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/13/2023
Initial Date FDA Received03/09/2023
Supplement Dates Manufacturer Received08/14/2023
Supplement Dates FDA Received08/16/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/30/2022
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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