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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HTL-STREFA S.A. DROPSAFE SAFETY NEEDLE 25G X 1ML; SYRINGE WITH SAFETY NEEDLE
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HTL-STREFA S.A. DROPSAFE SAFETY NEEDLE 25G X 1ML; SYRINGE WITH SAFETY NEEDLE Back to Search Results
Model Number DROPSAFE SAFETY NEEDLE 25G X 1ML
Device Problem Fail-Safe Problem (2936)
Patient Problem Needle Stick/Puncture (2462)
Event Type  malfunction  
Event Description
The safety needle does not close properly or all the way so it is a hazard for our employees.We did have a recent needle stick in the clinic but medical attn was not required.
 
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Brand Name
DROPSAFE SAFETY NEEDLE 25G X 1ML
Type of Device
SYRINGE 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
justyna zemigala
adamowek 7
ozorkow, 95-03-5
PL   95-035
MDR Report Key14883790
MDR Text Key303267382
Report Number9613304-2022-00007
Device Sequence Number1
Product Code FMF
UDI-Device Identifier85907996099319
UDI-Public(01)85907996099319(17)260401(10)SN25250018
Combination Product (y/n)N
PMA/PMN Number
K170651
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation Nurse
Type of Report Initial
Report Date 07/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberDROPSAFE SAFETY NEEDLE 25G X 1ML
Device Catalogue Number6059
Device Lot NumberSN25250018
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/31/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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