FDA Adverse Event
Malfunction
Summary report: N
CODAN TRIFURCATED EXTENSION SET
MDR report key: 10791992
·
Received November 5, 2020
Report
- Report Number
- 10791992
- Event Type
- Malfunction
- Date Received
- November 5, 2020
- Date of Event
- October 4, 2020
- Report Date
- October 20, 2020
- Manufacturer
- CODAN US CORPORATION
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
ATTEMPTED TO DISCONNECT TRIFUSER FROM CVC TO UNTANGLE TUBES/LINES AND THE TRIFUSER CRUMBLED UPON TURNING AND THE END OF THE TRIFUSER WAS LEFT IN THE MICROCLAVE. THE WHOLE END THEN BROKE OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1260545 | CODAN TRIFURCATED EXTENSION SET | SET, ADMINISTRATION, INTRAVASCULAR | FPA | CODAN US CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |