CYTOLYT SOLUTION CENTRIFUGE TUBE (30 ML) 0200012 0236080

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2000-05-11 for CYTOLYT SOLUTION CENTRIFUGE TUBE (30 ML) 0200012 0236080 manufactured by Cytyc Corporation.

Event Text Entries

[191504] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1222780-2000-00001
MDR Report Key277321
Report Source00
Date Received2000-05-11
Date of Report2000-05-11
Date of Event2000-04-13
Date Added to Maude2000-05-15
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactDAN BRACCO
Manufacturer Street85 SWANSON ROAD
Manufacturer CityBOXBOROUGH MA 01719
Manufacturer CountryUS
Manufacturer Postal01719
Manufacturer Phone9782663103
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCYTOLYT SOLUTION CENTRIFUGE TUBE (30 ML)
Generic NameTRANSPORT MEDIUM FOR CYTOLOGIC SAMPLES
Product CodeIFB
Date Received2000-05-11
Model Number0200012
Catalog Number0236080
Lot NumberNI
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key268423
ManufacturerCYTYC CORPORATION
Manufacturer Address85 SWANSON ROAD BOXBOROUGH MA 01719 US
Baseline Brand NameCYTOLYT SOLUTION CENTRIFUGE TUBE (30ML)
Baseline Generic NameCYTOLYT TUBE
Baseline Model No0200012
Baseline Catalog No0236080
Baseline IDNA
Baseline Device FamilySOLUTIONS (NON-GYN)
Baseline Shelf Life ContainedY
Baseline Shelf Life [Months]24
Baseline PMA FlagN
Baseline 510K PMNN
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptY


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2000-05-11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.