FDA Adverse Event
Malfunction
Summary report: N
CYTORICH
MDR report key: 20963372
·
Received December 18, 2024
Report
- Report Number
- 20963372
- Event Type
- Malfunction
- Date Received
- December 18, 2024
- Date of Event
- November 18, 2024
- Report Date
- December 3, 2024
- Manufacturer
- THERMO FISHER SCIENTIFIC, INC
- Product Code
- LEA
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CT
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
EVENT #1: [REDACTED DATE], THE CYTORICH CAPS ARE SPLIT AT THE TOP OF THE CAPS X 3. ALL FROM LOT: 144469. EVENT #2: [REDACTED DATE], CYTORICH RED (REF B9990802, LOT 14469, EXP [REDACTED DATE]) VIALS PICKED FOR CASES CONTINUE TO HAVE CRACKED LIDS. ONE WAS CAUGHT TODAY AS WE WERE PACKING UP THE SPECIMENS. LID EXCHANGED FOR A NEW ONE. IF NOT CAUGHT, IT WILL LEAD TO SPECIMEN LEAKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1437889 | CYTORICH | PRESERVATIVE, CYTOLOGICAL | LEA | THERMO FISHER SCIENTIFIC, INC | B9990802 | 144469 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Prefer Not To Disclose |