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

MAUDE Adverse Event Report: HIGH-FLO SUB-Q SINGLE NEEDLE 26GX9MM 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
 

HIGH-FLO SUB-Q SINGLE NEEDLE 26GX9MM SYRINGE, PISTON Back to Search Results
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/13/2020
Event Type  Injury  
Event Description
Syringe containing silicone may have been shipped with haegarda.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHIGH-FLO SUB-Q SINGLE NEEDLE 26GX9MM
Type of DeviceSYRINGE, PISTON
MDR Report Key9729150
MDR Text Key180611197
Report NumberMW5093096
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 Pharmacist
Type of Report Initial
Report Date 02/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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?
Type of Device Usage

-
-