FDA Adverse Event
Malfunction
Summary report: N
MAGELLAN NEEDLE 25 G 1 INCH
MDR report key: 8054923
·
Received November 8, 2018
Report
- Report Number
- MW5081161
- Event Type
- Malfunction
- Date Received
- November 8, 2018
- Date of Event
- November 5, 2018
- Report Date
- November 5, 2018
- Manufacturer
- COVIDIEN
- Product Code
- FMI
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
FOUND FIBER ATTACHED TO MAGELLAN 1 INCH 25 GAUGE LOT: 821923, EXP: 07/31/2023. DATES OF USE: (B)(6) 2018 - (B)(6) 2018.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 893108 | MAGELLAN NEEDLE 25 G 1 INCH | NEEDLE, HYPODERMIC SAFETY NEEDLE | FMI | COVIDIEN | 821923 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |