FDA Adverse Event
Malfunction
Summary report: N
RELI SAFETY HYPODERMIC NEEDLE
MDR report key: 20360238
·
Received October 2, 2024
Report
- Report Number
- MW5160473
- Event Type
- Malfunction
- Date Received
- October 2, 2024
- Date of Event
- September 25, 2024
- Report Date
- September 26, 2024
- Manufacturer
- RELI GEMTIER MEDICAL (SHANGHIA) INC./MYCO MEDICAL SUPPLIES, INC
- Product Code
- FMI
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- *
Narratives
Description of Event or Problem · 0
WHILE GIVING A VACCINE, UNABLE TO PUSH VACCINE INTO PATIENT. DUE TO ISSUE WITH THE NEEDLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2602395 | RELI SAFETY HYPODERMIC NEEDLE | NEEDLE, HYPODERMIC, SINGLE LUMEN | FMI | RELI GEMTIER MEDICAL (SHANGHIA) INC./MYCO MEDICAL SUPPLIES, INC | SHN23G101 | 20220604 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |