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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD PLASTIPAK 3 ML SYRINGE SYRINGE, PISTON

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BECTON, DICKINSON AND COMPANY BD PLASTIPAK 3 ML SYRINGE SYRINGE, PISTON Back to Search Results
Device Problem Contamination (1120)
Patient Problem Insufficient Information (4580)
Event Date 09/08/2021
Event Type  malfunction  
Event Description
Brand new package was opened and liquid was found inside syringe.
 
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Brand NameBD PLASTIPAK 3 ML SYRINGE
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY
1 becton drive
franklin lakes NJ 07417
MDR Report Key12532041
MDR Text Key273342887
Report Number12532041
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/20/2021
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/20/2021
Event Location Other
Date Report to Manufacturer09/27/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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