FDA Adverse Event
Malfunction
Summary report: N
ULTICARE TUBERCULIN SAFETY SYRINGE
MDR report key: 14712457
·
Received June 15, 2022
Report
- Report Number
- MW5110358
- Event Type
- Malfunction
- Date Received
- June 15, 2022
- Date of Event
- June 5, 2022
- Report Date
- June 13, 2022
- Manufacturer
- ULTI MED, INC.
- Product Code
- MEG
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
NEW TUBERCULIN SYRINGE BY ULTICARE 1.0ML IS SIMILAR TO INSULIN SYRINGE BY BD, SIMILAR CAP COLOR - HIGH RISK FOR STAFF TO MIX UP THE SYRINGES IN DRAWING UP MEDICATIONS MAY RESULT IN ADMINISTRATION ERROR. FDA SAFETY REPORT ID # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2365256 | ULTICARE TUBERCULIN SAFETY SYRINGE | SYRINGE, ANTISTICK | MEG | ULTI MED, INC. | 210610 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 01 DA | Prefer Not To Disclose | Other |