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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BC 3ML SYRINGE WITH LEUR-LOK TIP SYRINGE, PISTON

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BECTON DICKINSON BC 3ML SYRINGE WITH LEUR-LOK TIP SYRINGE, PISTON Back to Search Results
Catalog Number 309657
Device Problems Device Damaged Prior to Use (2284); Material Deformation (2976); Moisture or Humidity Problem (2986)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
A 3 ml syringe damaged in packaging, appearing heat warped and moisture in syringe. Fda safety report id # (b)(4). Fda safety received date: 01/30/2020.
 
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Brand NameBC 3ML SYRINGE WITH LEUR-LOK TIP
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
BECTON DICKINSON
franklin lakes NJ 07417
MDR Report Key9666284
MDR Text Key177883220
Report NumberMW5092731
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
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 01/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number309657
Device Lot Number9318766
Was Device Available for Evaluation? Yes
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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