MONOJECT SAFETY NDL 25 X 1
Report
- Report Number
- 1282497-2023-10802
- Event Type
- Malfunction
- Date Received
- October 26, 2023
- Date of Event
- September 14, 2023
- Report Date
- January 25, 2024
- Manufacturer
- CARDINAL HEALTH
- Product Code
- FMI
- UDI-DI
- 10884521544680
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ADDED ADDITIONAL INFORMATION TO SECTION B5 AND UPDATED THE HEALTH EFFECT - IMPACT CODE.
THIS REPORT WAS FILED IN ERROR. CARDINAL HEALTH IS NOT THE LEGAL MANUFACTURER OF THIS THIS DEVICE. THE LEGAL MANUFACTURER IS SOL MILLENNIUM MED INC. THE MANUFACTURER HAS BEEN NOTIFIED OF THE EVENT.
CORRECTION MADE TO THE VERBIAGE IN SECTION B5.
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
THE CUSTOMER REPORTED FAULTY SAFETY DEVICE (MULTIPLE NEEDLE STICKS). ADDITIONAL INFORMATION RECEIVED ON 06NOV2023 STATED THAT THEY CANNOT SAY AN EXACT NUMBER BUT THE PRODUCT WAS CHEAPLY MADE SO WHEN YOU WENT TO CLOSE THE SAFETY CLIP IT EITHER BENT THE NEEDLE OR THE CLIP DID NOT CLICK INTO PLACE LEAVING THE NEEDLE EXPOSED. THEY HAD TWO NEEDLE STICKS. BLOOD WORK WAS DONE ON THE PATIENT AND EMPLOYEE INVOLVED PER THEIR PROTOCOL.
THE CUSTOMER REPORTED A FAULTY SAFETY DEVICE. ADDITIONAL INFORMATION RECEIVED ON 06NOV2023 STATED THAT WHEN YOU WENT TO CLOSE THE SAFETY CLIP IT EITHER BENT THE NEEDLE OR THE CLIP DID NOT CLICK INTO PLACE LEAVING THE NEEDLE EXPOSED RESULTING IN A NEEDLE STICK. BLOOD WORK WAS DONE ON THE PATIENT AND EMPLOYEE INVOLVED PER THEIR PROTOCOL.
THE CUSTOMER REPORTED FAULTY SAFETY DEVICE (MULTIPLE NEEDLE STICKS).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1674898 | MONOJECT SAFETY NDL 25 X 1 | NEEDLE, HYPODERMIC, SINGLE LUMEN | FMI | CARDINAL HEALTH | 1182510 | 02112003 | 10884521544680 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |