MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2002-09-17 for PRESERVCYT SOLUTION VIAL ASSEMBLY 70098-001 manufactured by Cytyc Corp.
[16361383]
A nurse clincian had been splashed in the eyes during the process of transferring a gynecological sample from the cytobrush/spatula collection devices to the presercyt solution vial. The dr had the nurse clinican rinse their eyes according to the msds for preservcyt solution and also treated pt with antibiotic eye drops as a precationary measure. The nurse clinician reported that they experienced redness and irritation in their eyes for about 24 hours after the incident but that it cleared up soon after. Pt has experienced no lingering effects as of 9/2002. If cytyc obtains additional info it will be forwarded to the fda via a supplemental report. The nurse clinician also indicated that they typically dispensed the sample into the vial by scraping the cytobrush with the spatula and that they had been splashed in the eyes on previous occasions using this method. The nurse clinician was informed that cytyc's recommended collection protocol could be found in the "instructions for use" insert which is distributed with the collection devices. Cytyc technical support has confirmed that the pmr has followed up with the dr and the nurse clinician on the proper method of collecting a gynecological sample to be processed using the thinprep system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2002-00003 |
| MDR Report Key | 418409 |
| Report Source | 05,06,07 |
| Date Received | 2002-09-17 |
| Date of Report | 2002-09-11 |
| Date of Event | 2002-08-22 |
| Date Added to Maude | 2002-09-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DAN BRACCO |
| Manufacturer Street | 85 SWANSON ROAD |
| Manufacturer City | BOXBOROUGH MA 01719 |
| Manufacturer Country | US |
| Manufacturer Postal | 01719 |
| Manufacturer Phone | 9782663103 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRESERVCYT SOLUTION VIAL ASSEMBLY |
| Generic Name | REAGENT FOR CYTOLOGY SLIDE PREPARATION |
| Product Code | LEA |
| Date Received | 2002-09-17 |
| Model Number | 70098-001 |
| Catalog Number | 70098-001 |
| Lot Number | NI |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 407443 |
| Manufacturer | CYTYC CORP |
| Manufacturer Address | 85 SWANSON RD BOXBOROUGH MA 01719 US |
| Baseline Brand Name | PRESERVCYT SOLUTION VIAL ASSEMBLY |
| Baseline Generic Name | REAGENT FOR CYTOLOGY SLIDE PREPARATION |
| Baseline Model No | 70098-001 |
| Baseline Catalog No | 70098-001 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2002-09-17 |