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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 1ML 27G X 1/2 SYRINGE, PISTON

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BECTON DICKINSON SYRINGE 1ML 27G X 1/2 SYRINGE, PISTON Back to Search Results
Lot Number 0275305
Device Problem Contamination (1120)
Patient Problem Insufficient Information (4580)
Event Date 05/31/2021
Event Type  malfunction  
Event Description
Noticed that one of the syringes was dirty, black and brown, however the package was sealed and intact. Fda safety report id # (b)(4).
 
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Brand NameSYRINGE 1ML 27G X 1/2
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
BECTON DICKINSON
MDR Report Key11929926
MDR Text Key254376544
Report NumberMW5101685
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number0275305
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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