FDA Adverse Event
Malfunction
Summary report: N
VISITEC¿
MDR report key: 13023597
·
Received December 16, 2021
Report
- Report Number
- 1211998-2021-00070
- Event Type
- Malfunction
- Date Received
- December 16, 2021
- Date of Event
- November 24, 2020
- Report Date
- December 16, 2021
- Manufacturer
- BEAVER-VISITEC INTERNATIONAL, INC.
- Product Code
- HMX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
"CUSTOMER STATED THE BSS FLUID WOULD NOT ADVANCE THROUGH THREE OF THE CANNULAS". (1 OF 3)- PART OF RETROSPECTIVE REVIEW.
Additional Manufacturer Narrative · 0
"CUSTOMER STATED THE BSS FLUID WOULD NOT ADVANCE THROUGH THREE OF THE CANNULAS". (1 OF 3)- PART OF RETROSPECTIVE REVIEW.
Description of Event or Problem · 0
"CUSTOMER STATED THE BSS FLUID WOULD NOT ADVANCE THROUGH THREE OF THE CANNULAS". (1 OF 3)- PART OF RETROSPECTIVE VIEW.
Description of Event or Problem · 0
"CUSTOMER STATED THE BSS FLUID WOULD NOT ADVANCE THROUGH THREE OF THE CANNULAS". (1 OF 3)- PART OF RETROSPECTIVE VIEW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1921539 | VISITEC¿ | ANTERIOR CHAMBER CANNULA VISITEC | HMX | BEAVER-VISITEC INTERNATIONAL, INC. | 6034852 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |