MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-05-04 for VENOSCOPE II NT01 * manufactured by Venoscope.
[379481]
A venoscope ii neonatal transilluminator was used to identify a vein for a peripheral iv insertion. After insertion of the iv in the right forearm, a burn blister was noted on the posterior aspect of the right forearm below the elbow. Biomedical engineering analysis revealed that 2 units that were recently purchased (the only ones of this type in the facility) had led's (light emitting diodes) at the end of the transilluminator that get warm. With minimal pressure, they get hot enough to cause burning in infants. The manufacturer owner was contacted and admits that a 'batch' of these have reversed wiring. However, no markings or serial or lot numbers could be found on the device that would identify which devices are defective.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 600740 |
| MDR Report Key | 600740 |
| Date Received | 2005-05-04 |
| Date of Report | 2005-05-04 |
| Date of Event | 2005-04-28 |
| Report Date | 2005-05-04 |
| Date Reported to FDA | 2005-05-04 |
| Date Added to Maude | 2005-05-11 |
| 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 |
| 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 | VENOSCOPE II |
| Generic Name | NEONATAL TRANSILLUMINATOR |
| Product Code | HJN |
| Date Received | 2005-05-04 |
| Model Number | NT01 |
| Catalog Number | * |
| Lot Number | NONE |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 1 MO |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 590574 |
| Manufacturer | VENOSCOPE |
| Manufacturer Address | 128 DEMANADE BLVD, SUITE 301 LAFAYETTE LA 70503 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-05-04 |