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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE S2 2ML

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BECTON DICKINSON, S.A. SYRINGE S2 2ML Back to Search Results
Catalog Number 300928
Device Problem Volume Accuracy Problem (1675)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/06/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used. 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 that syringe s2 2ml had scale marking issues. The following information was provided by the initial reporter: the vaccination center reports that the 0,5 ml scale mark of the 2 ml syringe on the right side is defect.
 
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Brand NameSYRINGE S2 2ML
Type of DeviceSYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga, huesca 22520
SP 22520
Manufacturer (Section G)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga, huesca 22520
SP 22520
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12271803
MDR Text Key264957224
Report Number3002682307-2021-00382
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300928
Device Lot Number2007165
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/14/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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