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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE FLU PLUS 0.25-1ML VAR DOSE 23X1 PISTON SYRINGE

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BECTON DICKINSON, S.A. SYRINGE FLU PLUS 0.25-1ML VAR DOSE 23X1 PISTON SYRINGE Back to Search Results
Catalog Number 305832
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/02/2021
Event Type  malfunction  
Manufacturer Narrative
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 syringe flu plus 0. 25-1ml var dose 23x1 experienced leakage. The following information was provided by the initial reporter: drawing up vaccine with bd flu+ syringe 0. 25-1ml, lot no 2101 405 expiry 2021-12-31 and noticed vaccine coming past the bung/ plunger- faulty syringe, noticed before giving to patient, no injury. Syringe discarded, staff advised to be vigilant - previous issue with lifelong safeway 2ml syringes with fluid 'bleeding' behind bung/ plunger.
 
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Brand NameSYRINGE FLU PLUS 0.25-1ML VAR DOSE 23X1
Type of DevicePISTON SYRINGE
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 Key12436002
MDR Text Key270299709
Report Number3002682307-2021-00462
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K091377
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
Report Date 08/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number305832
Device Lot Number2101405
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 Received08/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/05/2021
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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