MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-05-10 for TRANSDUCER PROTECTOR DOUBLE LUER 0493072 manufactured by Gelman Sciences.
[14062]
Facility alleges transducer protector leaked and lost pressure causing blood to flow up to monitor line and fill up the transducer. Device required frequent changes. Venous line replaced due to clotting. Ebl >100cc.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243621-1995-00482 |
| MDR Report Key | 22309 |
| Date Received | 1995-05-10 |
| Date of Report | 1995-05-08 |
| Date of Event | 1995-04-06 |
| Date Facility Aware | 1995-05-08 |
| Report Date | 1995-05-08 |
| Date Reported to FDA | 1995-05-08 |
| Date Reported to Mfgr | 1995-05-08 |
| Date Added to Maude | 1995-06-08 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANSDUCER PROTECTOR |
| Generic Name | TRANSDUCER PROTECTOR |
| Product Code | FIB |
| Date Received | 1995-05-10 |
| Model Number | DOUBLE LUER |
| Catalog Number | 0493072 |
| Lot Number | UNKNOWN |
| Device Availability | * |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 22435 |
| Manufacturer | GELMAN SCIENCES |
| Manufacturer Address | 600 SOUTH WAGNER RD. ANN HARBOR MI 48106 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1995-05-10 |