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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE SAFETY LANCET PRESSURE ACTIVATE 30GX1.5MM 2000CT; SINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE
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MEDLINE INDUSTRIES, INC. MEDLINE SAFETY LANCET PRESSURE ACTIVATE 30GX1.5MM 2000CT; SINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE Back to Search Results
Model Number MPHPRESS30
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/10/2022
Event Type  malfunction  
Event Description
Health care provider went to do a blood sugar test on a patient and when twisted the lancet top off, the whole lancet came out.This is the third time this has happened in the last few weeks with the lancets to do blood sugars test.This is a safety issue due to the lancet coming out of the device that protects it.
 
Event Description
Health care provider went to do a blood sugar test on a patient and when twisted the lancet top off, the whole lancet came out.This is the third time this has happened in the last few weeks with the lancets to do blood sugars test.This is a safety issue due to the lancet coming out of the device that protects it.
 
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Brand Name
MEDLINE SAFETY LANCET PRESSURE ACTIVATE 30GX1.5MM 2000CT
Type of Device
SINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC.
one medline pl
mundelein IL 60060
MDR Report Key15893120
MDR Text Key304602440
Report Number15893120
Device Sequence Number1
Product Code FMK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberMPHPRESS30
Device Lot Number21082171-01
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/16/2022
Event Location Hospital
Date Report to Manufacturer12/01/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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