FDA Adverse Event
Malfunction
Summary report: N
BEAVER
MDR report key: 14605771
·
Received June 6, 2022
Report
- Report Number
- 1211998-2022-00039
- Event Type
- Malfunction
- Date Received
- June 6, 2022
- Date of Event
- May 10, 2022
- Report Date
- April 6, 2023
- Manufacturer
- BEAVER-VISITEC INTERNATIONAL, INC.
- Product Code
- HNN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
(B)(4) (2 OF 5).
Additional Manufacturer Narrative · 0
THE UDI NUMBER WAS UPDATED. 2 OF 5
Additional Manufacturer Narrative · 0
THE UDI NUMBER WAS ADDED TO THIS REPORT AND THE FOLLOWING SECTIONS WERE UPDATED : TYPE OF INVESTIGATION. INVESTIGATION FINDINGS. INVESTIGATION CONCLUSION . (2 OF 5).
Description of Event or Problem · 0
A CUSTOMER ALLEGED THAT THE SAFETY SHIELD ON THE SIDEPORT KNIFE 20G ANGL MVR W/SAFETY (10/SP) WAS IDENTIFIED AS RETRACTED PRIOR TO USE. THERE WAS NO PATIENT OR USER INVOLVEMENT AND NO INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 324747 | BEAVER | SIDEPORT KNIFE 20G ANGL MVR W/SAFETY | HNN | BEAVER-VISITEC INTERNATIONAL, INC. | 6048233 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |