FDA Adverse Event
Malfunction
Summary report: N
JELCO
MDR report key: 20694275
·
Received November 15, 2024
Report
- Report Number
- 20694275
- Event Type
- Malfunction
- Date Received
- November 15, 2024
- Date of Event
- October 2, 2022
- Report Date
- October 24, 2024
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- FMI
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
OUR OFFICE HAS RECEIVED OVER 30 REPORTS FOR THE SAME PRODUCT SMITH NEEDLES REF 4292, 25X1 NEEDLES REGARDING THEM LEAKING AS WELL AS BREAKING OFF THE SYRINGE. WE ALSO RECEIVED REPORTS OF HEALTH PROVIDERS STICKING PATIENTS WITH THE NEEDLES AND THEN UPON RETRACT, THEY BREAKING AND GETTING STUCK WITHIN THE PATIENTS. MANUFACTURER RESPONSE FOR SMITH REF 402558, SMITH (PER SITE REPORTER). NO RESPONSE AND NO ACTION. MANUFACTURER RESPONSE FOR SMITH NEEDLE HYPODERMIC NEEDLE-PRO, 25GX1 IN (REF 4292), SMITH (PER SITE REPORTER). NO RESPONSE OR ACTION PROVIDED BY SALES REP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1306654 | JELCO | NEEDLE, HYPODERMIC, SINGLE LUMEN | FMI | SMITHS MEDICAL ASD, INC. | 4292 | LOT#4120953; 4112029 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |