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

MAUDE Adverse Event Report: HTL-STREFA S.A. DROPSAFE SYRINGE WITH SAFETY NEEDLE

  • 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
 

HTL-STREFA S.A. DROPSAFE SYRINGE WITH SAFETY NEEDLE Back to Search Results
Model Number 25G X 1
Device Problem Fail-Safe Did Not Operate (4046)
Patient Problem Needle Stick/Puncture (2462)
Event Type  malfunction  
Event Description
While providing a covid vaccine, two nurses sustained needlestick injuries with drop safe syringe with safety needle. The safety did not engage properly resulting in needlesticks in the thumbs of the nurses.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDROPSAFE SYRINGE WITH SAFETY NEEDLE
Type of DeviceSYRINGE WITH SAFETY NEEDLE
Manufacturer (Section D)
HTL-STREFA S.A.
adamowek 7
ozorkow, 95-03 5
PL 95-035
Manufacturer (Section G)
HTL-STREFA S.A.
adamowek 7
ozorkow, 95-03 5
PL 95-035
Manufacturer Contact
aleksandra prazmowska-wilanowska
adamowek 7
ozorkow, 95-03-5
PL   95-035
MDR Report Key11918882
MDR Text Key259352389
Report Number9613304-2021-00023
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170651
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Type of Report Initial
Report Date 05/06/2021
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 Model Number25G X 1
Device Catalogue Number6055
Device Lot Number325250007
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-