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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE

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BECTON DICKINSON, S.A. BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE Back to Search Results
Catalog Number 300865
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/24/2021
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 bd plastipak¿ 50ml concentric luer lock syringe experienced separation between the syringe and mating component. The following information was provided by the initial reporter: syringe/3-way valve junction broke during administration of iv treatments.
 
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 bd plastipak¿ 50ml concentric luer lock syringe experienced separation between the syringe and mating component. The following information was provided by the initial reporter: syringe/3-way valve junction broke during administration of iv treatments.
 
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Brand NameBD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE
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 Key13101349
MDR Text Key285621342
Report Number3003152976-2021-00865
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeFR
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 01/27/2022
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 Number300865
Device Lot Number2108114
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/14/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/27/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/06/2021
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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