MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-09-07 for ULTRASOUND GEL * manufactured by Unk.
[504220]
A pt in isolation was ordered an ultrasound. The ultrasound technician felt the tube of ultrasound gel would be contaminated if the whole tube was taken into the room. The technician withdrew some of the ultrasound gel into an iv syringe and brought that into the room. The unused portion was left on the pt cart just outside the room unlabeled and unattended. During a mock inspection the blue tint ultrasound gel, approixmately 8 ml, was found in the unlabeled iv syringe on the cart that is frequently accessed by many to prepare medications. It was not administered to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4004006 |
| MDR Report Key | 759134 |
| Date Received | 2005-09-07 |
| Date Added to Maude | 2006-09-13 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PHARMACIST |
| 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 | ULTRASOUND GEL |
| Generic Name | ULTRASOUND GEL |
| Product Code | MJS |
| Date Received | 2006-09-07 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 747048 |
| Manufacturer | UNK |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-09-07 |