MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-12-09 for KLEENSPEC 78810 * manufactured by Welch Allyn, Inc..
[16036284]
Nurse attempted to start a peripheral intravenous catheter using a transilluminator for assistance locating a vein. Instead of the transilluminator, he mistakenly used a vaginal illuminator, which caused the patient to receive 2nd degree burns on the palm and on the forearm. The vaginal illuminator looks significantly similar to the transilluminator and it had been placed in the same area where the transilluminator was kept. Although the nurse recognized it did not look exactly the same, he knew that there were plans to purchase new transilluminators recently and mistakenly assumed the vaginal illuminator was one of the new ones. It was not. These two pieces of equipment are never stored together and we do not know how it got where it was. We hope to get to the root cause of that, as well as formulate action plans so that this does not happen again.
Patient Sequence No: 1, Text Type: D, B5
[16166663]
Nurse attempted to start a peripheral intravenous catheter using a transilluminator for assistance locating a vein. Instead of the transilluminator, he mistakenly used a vaginal illuminator, which caused the patient to receive 2nd degree burns on the palm and on the forearm. The vaginal illuminator looks significantly similar to the transilluminator and it had been placed in the same area where the transilluminator was kept. Although the nurse recognized it did not look exactly the same, he knew that there were plans to purchase new transilluminators recently and mistakenly assumed the vaginal illuminator was one of the new ones. It was not. These two pieces of equipment are never stored together and we do not know how it got where it was. We hope to get to the root cause of that, as well as formulate action plans so that this does not happen again.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1559326 |
| MDR Report Key | 1559326 |
| Date Received | 2009-12-09 |
| Date of Report | 2009-12-09 |
| Date of Event | 2009-11-11 |
| Report Date | 2009-12-09 |
| Date Reported to FDA | 2009-12-09 |
| Date Added to Maude | 2009-12-15 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| 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 | KLEENSPEC |
| Generic Name | ILLUMINATOR, VAGINAL |
| Product Code | FTF |
| Date Received | 2009-12-09 |
| Model Number | 78810 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WELCH ALLYN, INC. |
| Manufacturer Address | 4341 STATE STREET ROAD SKANEATELES FALLS NY 13153022 US 13153 0220 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-12-09 |