FDA Adverse Event
Malfunction
Summary report: N
LB53 LIGHT HANDLE COVER
MDR report key: 17912534
·
Received October 11, 2023
Report
- Report Number
- 1043572-2023-00147
- Event Type
- Malfunction
- Date Received
- October 11, 2023
- Date of Event
- September 15, 2023
- Report Date
- October 11, 2023
- Manufacturer
- STERIS CORPORATION
- Product Code
- FTA
- UDI-DI
- 00724995150136
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
STERIS HAS CONFIRMED THE REPORTED ISSUE. THE POLYBLEND PLASTIC MATERIAL THAT IS USED TO FORM THE LIGHT HANDLE COVER WAS SOURCED FROM A SECONDARY SUPPLIER BEGINNING IN (B)(6) 2022 AND MAY NOT MEET PERFORMANCE SPECIFICATIONS. STERIS INITIATED A RECALL (REMOVAL) OF THE AFFECTED PRODUCT ON (B)(6) 2023.
Additional Manufacturer Narrative · 0
UDI RELATED DATA QUALITY UPDATES ONLY - ALIGNMENT WITH GUDID.
Description of Event or Problem · 0
THE USER FACILITY REPORTED THAT DURING PATIENT PROCEDURES THEIR LIGHT HANDLE COVERS DETACHED AND FELL. NO REPORT OF INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2067634 | LB53 LIGHT HANDLE COVER | LB53 LIGHTHANDLE COVER | FTA | STERIS CORPORATION | STERILE LIGHTHANDLE COVER | (10)9799098A | 00724995150136 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |