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U.S. Department of Health and Human Services

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

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BECTON DICKINSON, S.A. BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE Back to Search Results
Catalog Number 300865
Device Problems Leak/Splash (1354); Volume Accuracy Problem (1675)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/30/2021
Event Type  malfunction  
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Brand NameBD PLASTIPAK 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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12535215
Report Number3003152976-2021-00636
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 foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300865
Device Lot Number2105104
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 Received08/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/24/2021
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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