FDA Adverse Event
Malfunction
Summary report: N
SYRINGE BARRELS
MDR report key: 18535138
·
Received January 17, 2024
Report
- Report Number
- MW5150464
- Event Type
- Malfunction
- Date Received
- January 17, 2024
- Report Date
- January 16, 2024
- Manufacturer
- FEEL TECH BIO CO., LTD.
- Product Code
- FMF
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- UNKNOWN
- Health Professional
- *
Narratives
Description of Event or Problem · 0
OUR INSULIN SYRINGES WENT ON BACK ORDER. EASY TOUCH U-100 INSULIN SYRINGE BARRELS, 1ML SYRINGES. WE HAD ALSO ORDERED EASY TOUCH SYRINGE BARRELS, 1ML SYRINGES. I HAVE INCLUDED PICTURES OF THE PRODUCTS. WE PUT A 1CC SYRINGE IN WITH INSULIN INSTEAD OF THE 100 UNIT SYRINGE. THERE WAS NO ERROR, THE INSULIN WAS GIVEN CORRECTLY. (B)(4) REF REPORT: MW5150463.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 87 | SYRINGE BARRELS | SYRINGE, PISTON | FMF | FEEL TECH BIO CO., LTD. | 64031 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |