MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-05 for VENTRICULOSTOMY SET manufactured by Integra Lifesciences Corporation.
[182191527]
Upon first encounter with patient left ventriculostomy was found to be broken at the point where the transducer attaches to buretrol. Cerebrospinal fluid was found to be dripping out at this particular point. Patient was alert and talking. No harm was immediately recognized. Ventric was clamped to patient and sterile gauze was wrapped around both open ports in the system to help prevent infection. Picu resident as well as neurosurgery resident were paged. A new ventriculostomy was set up per protocol and neurosurgery was at bedside to replace unit. Old broken unit was saved and tagged in order to be reviewed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9792730 |
| MDR Report Key | 9792730 |
| Date Received | 2020-03-05 |
| Date of Report | 2019-12-06 |
| Date of Event | 2019-06-05 |
| Report Date | 2019-12-09 |
| Date Reported to FDA | 2019-12-09 |
| Date Reported to Mfgr | 2020-03-05 |
| Date Added to Maude | 2020-03-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VENTRICULOSTOMY SET |
| Generic Name | SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS |
| Product Code | JXG |
| Date Received | 2020-03-05 |
| Lot Number | 3291037 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Address | 1100 CAMPUS ROAD PRINCETON NJ 08540 US 08540 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-05 |