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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. TEMNO A.C.T NEEDLE FOR BIOPSY 18 G X 15 CM BIOPSY NEEDLE

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MERIT MEDICAL SYSTEMS, INC. TEMNO A.C.T NEEDLE FOR BIOPSY 18 G X 15 CM BIOPSY NEEDLE Back to Search Results
Model Number ACT1815
Device Problem Physical Resistance/Sticking (4012)
Patient Problem Insufficient Information (4580)
Event Date 11/15/2021
Event Type  malfunction  
Event Description
Pa prepping needle for biopsy. Inner cannula of needle would not disengage. Needle removed from sterile field and new biopsy needle obtained. Fda safety report id# (b)(4).
 
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Brand NameTEMNO A.C.T NEEDLE FOR BIOPSY 18 G X 15 CM
Type of DeviceBIOPSY NEEDLE
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS, INC.
south jordan
MDR Report Key12844208
MDR Text Key281110159
Report NumberMW5105471
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 11/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberACT1815
Device Catalogue NumberACT1815
Device Lot Number12127785
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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