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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD SYRINGES 3ML LL 22GA; PISTON SYRINGE
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BECTON DICKINSON DE MEXICO BD SYRINGES 3ML LL 22GA; PISTON SYRINGE Back to Search Results
Catalog Number 302541
Device Problem Complete Blockage (1094)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/23/2022
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 the bd syringes 3ml ll 22ga experienced blockage.The following information was provided by the initial reporter: when i wanted to apply the injection before taking the liquid from the vial, the syringe did not work, i think which is covered.
 
Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval yes.D9: returned to manufacturer on: 16-aug-2022.H6: investigation summary one sample and photos received for investigation.Upon visual inspection, no damage can be observed however the cannula appears inclined.Inclination measurement was performed, results were outside the specification limits.Additionally, functional testing was performed, result were found to be acceptable no clogged needle identified.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.Based on the available information, we are unable to identify a root cause related to the manufacturing process at this time.
 
Event Description
It was reported that the bd syringes 3ml ll 22ga experienced blockage.The following information was provided by the initial reporter: when i wanted to apply the injection before taking the liquid from the vial, the syringe did not work, i think which is covered.
 
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Brand Name
BD SYRINGES 3ML LL 22GA
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 Key14744329
MDR Text Key301918218
Report Number9614033-2022-00053
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,Consumer
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number302541
Device Lot Number0332987
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/16/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/20/2021
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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