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 2002-07-08 for PRESERVCYT SOLUTION VIAL ASSEMBLY 70098-001 manufactured by Cytyc Corp..
[276283]
In 2002, a customer, dr. , reported that in 2002 a nurse who was handling vial of preservcyt solution spilled a portion of the vial onto their finger, which had a cut on it. The pt whose sample was in the vial had tested positive for hepatitis c. Dr asked if the preservcyt solution would inactivate the hepatitis c in the sample. Technical support communicated to dr. , the preservcyt should be handled according to safe laboratory practices. Technical support also referred dr to the tp 2000 operator's manual which lists the viral and microbial organisms, which preservcyt inactivates. The nurse was treated for hepatitis c exposure as a precautionary measure. When contacted at a later date, dr stated he could not release any update on the nurse's condition citing pt confidentiality. There have been no further reports regarding the incident received by cytyc in the 25 days since ts first spoke with dr. If cytyc obtains additional info it will be forwarded to the fda via supplemental report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2002-00002 |
| MDR Report Key | 404190 |
| Report Source | 05,06,07 |
| Date Received | 2002-07-08 |
| Date of Report | 2002-07-01 |
| Date of Event | 2002-05-24 |
| Date Added to Maude | 2002-07-15 |
| 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 | 2002-07-08 |
| 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 | 393181 |
| 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 | 2002-07-08 |