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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ 20ML SYRINGE LUER-LOK¿ PISTON SYRINGE

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BECTON DICKINSON, S.A. BD PLASTIPAK¿ 20ML SYRINGE LUER-LOK¿ PISTON SYRINGE Back to Search Results
Catalog Number 300629
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/30/2021
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 2 bd plastipak¿ 20ml syringes luer-lok¿ experienced leakage past the plunger. The following information was provided by the initial reporter: we experienced issues with two bd plastipak luer-lok 20 ml syringes. The plunger rod did not seal up enough and the fluid passed the two black sealing membranes and the fluid leaked. Given the syringes are used in the production of cytostatics, there was a leak of cytostatic solution.
 
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 2 bd plastipak¿ 20ml syringes luer-lok¿ experienced leakage past the plunger. The following information was provided by the initial reporter: we experienced issues with two bd plastipak luer-lok 20 ml syringes. The plunger rod did not seal up enough and the fluid passed the two black sealing membranes and the fluid leaked. Given the syringes are used in the production of cytostatics, there was a leak of cytostatic solution.
 
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Brand NameBD PLASTIPAK¿ 20ML SYRINGE LUER-LOK¿
Type of DevicePISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer (Section G)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13101715
MDR Text Key285621060
Report Number3003152976-2021-00867
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 Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/16/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number300629
Device Lot Number2108060
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/07/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/16/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/03/2021
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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