FDA Adverse Event
Malfunction
Summary report: N
MEDLINE SAFETY LANCET PRESSURE ACTIVATE 30GX1.5MM 2000CT
MDR report key: 15893120
·
Received December 1, 2022
Report
- Report Number
- 15893120
- Event Type
- Malfunction
- Date Received
- December 1, 2022
- Date of Event
- November 10, 2022
- Report Date
- November 16, 2022
- Manufacturer
- MEDLINE INDUSTRIES, INC.
- Product Code
- FMK
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- UT
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
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.
Description of Event or Problem · 0
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2124357 | MEDLINE SAFETY LANCET PRESSURE ACTIVATE 30GX1.5MM 2000CT | SINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE | FMK | MEDLINE INDUSTRIES, INC. | MPHPRESS30 | 21082171-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |