MAGELLAN
Report
- Report Number
- 1423537-2024-00072
- Event Type
- Malfunction
- Date Received
- July 15, 2024
- Report Date
- September 18, 2025
- Manufacturer
- CARDINAL HEALTH, INC.
- Product Code
- FMI
- PMA / PMN Number
- K012736
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
INVESTIGATION SUMMARY: THE DEVICE HISTORY RECORD WAS REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. PICTURES WERE RECEIVED, AND THE REPORTED ISSUE WAS NOT OBSERVED. A ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. WE WILL CONTINUE TO MONITOR RELATED REPORTS TO DETERMINE IF ADDITIONAL ACTIONS ARE NECESSARY.
THE DEVICE HISTORY RECORD (DHR) FOR LOT 112744 WAS REVIEWED AND NO ANOMALIES RELATED TO THE REPORTED ISSUE WERE OBSERVED. PRIOR TO A LOT¿S RELEASE, THE LOT MUST BE DEEMED ACCEPTABLE BY PASSING INSPECTIONS THAT ARE BASED ON A VALID SAMPLING PLAN. DURING PRODUCTION, INSPECTORS ROUTINELY EXAMINE A STATISTICAL SAMPLE BOTH PHYSICALLY AND VISUALLY. ONE DEVICE WAS RETURNED FOR EVALUATION AND THE REPORTED ISSUE WAS OBSERVED. THE INVESTIGATION DID NOT IDENTIFY A SYSTEMIC ISSUE WITH THE PRODUCT OR PROCESS. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED BASED ON AVAILABLE INFORMATION. THEREFORE, A CORRECTIVE AND PREVENTIVE ACTION (CAPA) IS NOT NECESSARY AT THIS TIME. WE WILL CONTINUE TO MONITOR RELATED REPORTS TO DETERMINE IF ADDITIONAL ACTIONS ARE NECESSARY.
THE CUSTOMER REPORTED LEAKING AT THE CONNECTION. THE SUBSTANCE DID NOT ESCAPE THROUGH THE CANNULA, LIQUID OUT ON THE SIDE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1460103 | MAGELLAN | NEEDLE, HYPODERMIC, SINGLE LUMEN | FMI | CARDINAL HEALTH, INC. | 8881850310 | 112744 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |