FDA Adverse Event Other Summary report: N

CYTOLYT SOLUTION CENTRIFUGE TUBE (30 ML)

MDR report key: 277321 · Received May 11, 2000

Report

Report Number
1222780-2000-00001
Event Type
Other
Date Received
May 11, 2000
Date of Event
April 13, 2000
Report Date
May 11, 2000
Manufacturer
CYTYC CORPORATION
Product Code
IFB
Report Source
Manufacturer report
Reporter Location
VA, US
Reporter Occupation
NO INFORMATION

Narratives

Description of Event or Problem · 1

ON 04/13/2000, RPTR REPORTED AN INCIDENT TO TECHNICAL SVC (TS) THAT WAS REPORTED TO RPTR BY A NURSE PRACTITIONER. RN CLAIMED THAT CYTOLYT SOLUTION HAD BEEN ACCIDENTALLY SPLASHED INTO AN EMPLOYEE'S EYES. THE EMPLOYEE WHOSE NAME IS UNKNOWN AT THIS TIME IS A HOSP CONTRACT EMPLOYEE WORKING IN THE CYTOLOGY DEPT. TS CONTACTED RN WHO EXPLAINED THAT RPTR HAD REVIEWED WITH RN THE FIRST AID PROCEDURE FOUND ON THE CYTOLYT SOLUTION MATERIAL SAFETY DATA SHEET (MSDS). RN ENSURED THAT THE EMPLOYEE HAD RINSED EMPLOYEE'S EYES FOR 15 MINUTES AS SUGGESTED IN THE MSDS. SINCE RN WAS A NURSE PRACTITIONER, RN WAS ALSO ABLE TO PROVIDE THE EMPLOYEE WITH MEDICAL ATTENTION. RN HAD THE EMPLOYEE CONTINUE THE EYE RINSING. RN THEN HAD THE EMPLOYEE SPEAK TO THE TS REP WHO WAS ON THE PHONE AT THAT TIME. THE EMPLOYEE EXPLAINED THAT EMPLOYEE WASN'T EXACTLY SURE WHETHER THE EYE SPLASH WAS FROM THE CYTOLYT OR PRESERVCYT SOLUTION SINCE BOTH WERE PRESENT IN THE REFRIGERATOR AT THE TIME OF THE INCIDENT AND THAT EMPLOYEE'S HAND HAD ACCIDENTALLY HIT CONTAINERS OF EACH TYPE OF SOLUTION. FIRST AID TREATMENT FOR BOTH TYPES OF SOLUTION IS THE SAME, SO THERE WAS NO CONCERN THAT AN INAPPROPRIATE TREATMENT WAS ADMINISTERED. RN THEN RESUMED CONVERSATION WITH TS AND ASKED WHAT THE PH OF EACH SOLUTION WAS. TS INFORMED RN THAT CYTOLYT SOLUTION HAS A PH OF 7 AND PRESERVCYT SOLUTION HAS A PH OF 5.5. RN TOLD TS THAT NO FURTHER MEDICAL ATTENTION WOULD BE REQUIRED AFTER THE EYE RINSING. ON 04/14/2000, TS RECEIVED A CALL FROM RN WHO STATED THAT RN HAD POSITIVELY IDENTIFIED THE PARTICULAR CONTAINER OF SOLUTION THAT HAD SPLASHED INTO THE EMPLOYEE'S EYES. IT WAS A TUBE OF CYTOLYT SOLUTION THAT CONTAINED A BRONCHIAL SECRETION THAT HAD BEEN IN THE REFRIGERATOR FOR 2 DAYS. RN ASKED WHETHER OR NOT THE CYTOLYT SOLUTION WOULD INACTIVATE THE SPECIMEN. TS INFORMED RN THAT CYTOLYT SOLUTION IS A TRANSPORT MEDIUM THAT LYSES RED BLOOD CELLS, PREVENTS PROTEIN PRECIPITATION, AND DISSOLVES MUCUS, BUT IS NOT DESIGNED TO INACTIVATE A SPECIMEN. AFTER RECEIVING THIS INFO FROM TS, RN REITERATED THAT NO FURTHER MEDICAL ATTENTION WOULD BE NECESSARY. IF OR WHEN CYTYC OBTAINS ADDITIONAL INFO REGARDING THIS INCIDENT IT WILL BE FORWARDED TO THE FDA VIA A SUPPLEMENTAL REPORT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 CYTOLYT SOLUTION CENTRIFUGE TUBE (30 ML) TRANSPORT MEDIUM FOR CYTOLOGIC SAMPLES IFB CYTYC CORPORATION 0200012 NI

Patients

Seq Age Sex Outcome Treatment
1 NO INFO Other| R