FDA Adverse Event
Malfunction
Summary report: N
ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP
MDR report key: 15855376
·
Received November 23, 2022
Report
- Report Number
- 3011581906-2022-00229
- Event Type
- Malfunction
- Date Received
- November 23, 2022
- Date of Event
- November 11, 2022
- Report Date
- November 23, 2022
- Manufacturer
- INFUTRONIX, LLC.
- Product Code
- FPA
- PMA / PMN Number
- K153193
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
INFUTRONIX IS WAITING FOR THE AFFECTED DEVICE TO BE RETURNED.
Description of Event or Problem · 0
INFUTRONIX LLC RECEIVED A COMPLAINT FROM A HEALTHCARE PROFESSIONAL, WHO REPORTED "DIRTY TAPE ON THE INSIDE OF THE ADMINISTRATION SET". THIS WAS NOTICED WHEN THE ADMINISTRATION SET WAS OPENED. THERE WAS NO PATIENT INVOLVEMENT. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS PODO XINGDA (TIANJIN) MEDICAL CO. LTD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 314570 | ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP | IV ADMINISTRATION SET | FPA | INFUTRONIX, LLC. | HS-008 | 2208017 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |