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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD PLASTIPAK 10ML SYRINGE; PISTON SYRINGE
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BECTON DICKINSON DE MEXICO BD PLASTIPAK 10ML SYRINGE; PISTON SYRINGE Back to Search Results
Catalog Number 302555
Device Problem Complete Blockage (1094)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/01/2022
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 an unspecified number of bd plastipak 10ml syringes experienced clogged needles.The following information was provided by the initial reporter: nursing reports that when wanting to aspirate solution or medicine, the needle does not allow them to pass, since it is clogged; which causes loss for the hospital and the patient.
 
Manufacturer Narrative
H6: investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.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 an unspecified number of bd plastipak 10ml syringes experienced clogged needles.The following information was provided by the initial reporter: nursing reports that when wanting to aspirate solution or medicine, the needle does not allow them to pass, since it is clogged; which causes loss for the hospital and the patient.
 
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Brand Name
BD PLASTIPAK 10ML 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
8015296192
MDR Report Key14858878
MDR Text Key303260675
Report Number9614033-2022-00056
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 11/08/2022
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 Health Professional
Device Catalogue Number302555
Device Lot Number1286624
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/01/2022
Initial Date FDA Received06/29/2022
Supplement Dates Manufacturer Received11/08/2022
Supplement Dates FDA Received11/23/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/04/2021
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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