MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2001-10-03 for CYTOLYT SOLUTION CENTRIFUGE TUBE 0200012 0236080 manufactured by Cytyc Corporation.
[21956194]
In 2001, hospital called cytyc's technical svc dept asking the amount of methanol in cytolyt solution, as a pt drank a cup (30cc) of cytolyt. Technical svc advised that cytolyt contained 20% methanol. The pt had been in the hosp for a bronchoscopy and was to have another procedure, and in error, drank the cytolyt. The pt is currently being treated in icu. Customer did have an msds for cytolyt and had given it to the dr treating the pt in icu. The customer did not have an update of the pt's condition. The next day, technical svc called the customer but she did not have much info, as the drs were very busy. The customer did state they had pumped the pt's stomach and were monitoring the pt today. The next day, the customer called technical svc and indicated there were no traces of methanol found from the blood test on the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2001-00004 |
| MDR Report Key | 354772 |
| Report Source | 05,06 |
| Date Received | 2001-10-03 |
| Date of Report | 2001-09-28 |
| Date of Event | 2001-08-28 |
| Date Added to Maude | 2001-10-10 |
| 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 | CYTOLYT SOLUTION CENTRIFUGE TUBE |
| Generic Name | TRANSPORT MEDIUM FOR CYTOLYT SAMPLE |
| Product Code | IFB |
| Date Received | 2001-10-03 |
| Model Number | 0200012 |
| Catalog Number | 0236080 |
| Lot Number | NI |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 343993 |
| Manufacturer | CYTYC CORPORATION |
| Manufacturer Address | 85 SWANSON ROAD BOXBOROUGH MA 01719 US |
| Baseline Brand Name | CYTOLYT SOLUTION CENTRIFUGE TUBE (30ML) |
| Baseline Generic Name | CYTOLYT TUBE |
| Baseline Model No | 0200012 |
| Baseline Catalog No | 0236080 |
| Baseline ID | NA |
| Baseline Device Family | SOLUTIONS (NON-GYN) |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2001-10-03 |