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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD PLASTIPAK¿ LUER-LOK¿ SYRINGE; PISTON SYRINGE
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BECTON DICKINSON DE MEXICO BD PLASTIPAK¿ LUER-LOK¿ SYRINGE; PISTON SYRINGE Back to Search Results
Catalog Number 302542
Device Problem Complete Blockage (1094)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/13/2023
Event Type  malfunction  
Event Description
It was reported that 3 bd plastipak¿ luer-lok¿ syringes' needles were clogged during use.The following information was provided by the initial reporter, translated from spanish: "syringes clogged.".
 
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.
 
Manufacturer Narrative
H6: investigation summary: photo received by our quality team for investigation.Upon visual evaluation, blister pack is displayed with a syringe and needle attached.No defects or issues observed.Unable to confirm failure based on images, physical sample is necessary to further analyze.A device history review was performed for reported lot 1337130, maintenance records related to the failure were detected.Based on the quality team¿s previous investigations, the root cause is associated with effectiveness of the sensor.
 
Event Description
It was reported that 3 bd plastipak¿ luer-lok¿ syringes' needles were clogged during use.The following information was provided by the initial reporter, translated from spanish: "syringes clogged.".
 
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Brand Name
BD PLASTIPAK¿ LUER-LOK¿ 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 Key16510639
MDR Text Key310983603
Report Number9614033-2023-00015
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/20/2023
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 Catalogue Number302542
Device Lot Number1337130
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/13/2023
Initial Date FDA Received03/09/2023
Supplement Dates Manufacturer Received07/20/2023
Supplement Dates FDA Received08/07/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/15/2022
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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