MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-03-24 for MEDTRONIC VENTRICLEAR II VENTRICULAR DRAINAGE CATHETER UNKNOWN UNK manufactured by Medtronic Neurological Technologies.
[5602038]
A (b)(6) male involved in (b)(6) was admitted with acute subdural hematoma. Placement of in-dwelling catheter and external drainage system placed on (b)(6) 2015. While rn was doing the initial bag change for the evd, the bag was not able to be unscrewed from the drainage system. Rn asked md to attempt drainage bag disconnection. When md tried to disconnect the bag, the connection piece came apart. The drainage system was changed by md. Unknown potential patient harm. Dates of use: (b)(6) 2015.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5041741 |
| MDR Report Key | 4645587 |
| Date Received | 2015-03-24 |
| Date of Report | 2015-03-24 |
| Date of Event | 2015-03-22 |
| Date Added to Maude | 2015-04-01 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDTRONIC VENTRICLEAR II VENTRICULAR DRAINAGE CATHETER |
| Generic Name | VENTRICLEAR II VENTRICULAR DRAINAGE CATHETER |
| Product Code | OEI |
| Date Received | 2015-03-24 |
| Model Number | UNKNOWN |
| Catalog Number | UNK |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROLOGICAL TECHNOLOGIES |
| Manufacturer Address | 123 CEMONA DRIVE GOLETA CA 93117550 US 93117 550 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-24 |