FDA Adverse Event
Malfunction
Summary report: N
BEAVER
MDR report key: 14605869
·
Received June 6, 2022
Report
- Report Number
- 1211998-2022-00044
- 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
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
PIR: 333933 (2 OF 11).
Additional Manufacturer Narrative · 0
THE UDI NUMBER WAS UPDATED. 2 OF 11.
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 11).
Description of Event or Problem · 0
A CUSTOMER ALLEGED THAT THE SAFETY SHIELD ON THE SIDE PORT KNIFE 1MM ANGLED W/SAFETY 10/SP WAS IDENTIFIED AS RETRACTED AND A TECH PRICKED HER FINGER. NO MEDICAL INTERVENTION WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 578108 | BEAVER | SIDEPORT KNIFE 1MM ANGLED W/SAFETY | HNN | BEAVER-VISITEC INTERNATIONAL, INC. | 60494441 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |