FDA Adverse Event
Other
Summary report: N
MICROLET LANCET
MDR report key: 648975
·
Received December 1, 2005
Report
- Report Number
- 1826988-2005-00078
- Event Type
- Other
- Date Received
- December 1, 2005
- Date of Event
- November 8, 2005
- Report Date
- November 9, 2005
- Manufacturer
- BAYER HEALTHCARE, LLC
- Product Code
- FMK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
AT BLOOD COLLECTION FROM PT'S EARLOBE, THE NEEDLE PIERCED THROUGH THE PT'S EARLOBE AND PUNCTURED THE NURSE'S FINGER. AFTER FURTHER INVESTIGATION IT WAS NOTED THAT THE NEEDLE WAS PROTRUDING TOO FAR OUT OF THE LANCET BODY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICROLET LANCET | LANCET, BLOOD | FMK | BAYER HEALTHCARE, LLC | 6545P | J16G5 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |