FDA Adverse Event
Malfunction
Summary report: N
HYDRA
MDR report key: 19719263
·
Received July 11, 2024
Report
- Report Number
- 3005099803-2024-02981
- Event Type
- Malfunction
- Date Received
- July 11, 2024
- Date of Event
- April 2, 2024
- Report Date
- July 11, 2024
- Manufacturer
- JIANGSU JIANYU HEALTH MEDICAL CO LTD
- Product Code
- FEQ
- UDI-DI
- 00840253108425
- PMA / PMN Number
- K161482
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK H6: IMDRF DEVICE CODE A140507 CAPTURES THE REPORTABLE EVENT OF REFLUX WITHIN DEVICE.
Description of Event or Problem · 0
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT HYDRA IRRIGATION TUBING WAS USED IN AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE WATER FLEW BACK DURING IRRIGATION. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATION AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 272668 | HYDRA | PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE | FEQ | JIANGSU JIANYU HEALTH MEDICAL CO LTD | SIT-575-15 | 0000230415 | 00840253108425 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |