• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DUOPROSS MEDITECH CORPORATION DUOPROSS 3 ML SYRINGE WITH 21G 1" NEEDLE SYRINGE, PISTON

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DUOPROSS MEDITECH CORPORATION DUOPROSS 3 ML SYRINGE WITH 21G 1" NEEDLE SYRINGE, PISTON Back to Search Results
Lot Number 20180714
Device Problem Crack (1135)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  No Answer Provided  
Event Description
Syringe barrels have cracks that allow liquid to be released as the plunger is extended or depressed. (b)(6).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDUOPROSS 3 ML SYRINGE WITH 21G 1" NEEDLE
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
DUOPROSS MEDITECH CORPORATION
MDR Report Key8208532
MDR Text Key132046063
Report NumberMW5082731
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Lot Number20180714
Was Device Available for Evaluation? No Answer Provided
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?
Type of Device Usage

-
-