FDA Adverse Event
Malfunction
Summary report: N
THE BELMONT 3-SPIKE DISPOSABLE SET
MDR report key: 7911960
·
Received September 26, 2018
Report
- Report Number
- 1219702-2018-00032
- Event Type
- Malfunction
- Date Received
- September 26, 2018
- Date of Event
- August 25, 2018
- Report Date
- September 26, 2018
- Manufacturer
- BELMONT INSTRUMENT LLC
- Product Code
- LGZ
- UDI-DI
- 00896128002022
- PMA / PMN Number
- K141654
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
WE WERE UNABLE TO CONFIRM THE CUSTOMER COMPLAINT REGARDING A LEAK, AS THE DISPOSABLE SET WAS DISCARDED AT THE HOSPITAL AND COULD NOT BE RETURNED FOR INVESTIGATION. THE RETENTION SAMPLE OF THE ASSOCIATED LOT WAS TESTED AND NO LEAKS WERE OBSERVED. THERE HAVE BEEN NO OTHER INCIDENTS REPORTED INVOLVING THIS LOT. IT WAS REPORTED THAT THERE WAS NO INJURY TO THE PATIENT.
Description of Event or Problem · 1
ON AUGUST 27, 2018, THE BELMONT SALES REPRESENTATIVE RECEIVED A CALL FROM THE CLINICAL EDUCATOR AT (B)(6) HOSPITAL, WHO REPORTED THAT THE STAFF NOTICED A LEAK COMING FROM THE TOP OF THE 3-SPIKE DISPOSABLE SET DURING USE OF THE BELMONT RAPID INFUSER. THE DISPOSABLE SET WAS SUBSEQUENTLY DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 752686 | THE BELMONT 3-SPIKE DISPOSABLE SET | THERMAL INFUSION FLUID WARMER | LGZ | BELMONT INSTRUMENT LLC | 3-SPIKE DISPOSABLE SET | 2018-04 02 | 00896128002022 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |