MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-23 for VENTRICLEAR II VENTRICULAR DRAINAGE COLLECTION SYSTEM UNK manufactured by Medtronic Neurologic Technologies.
[29939413]
A (b)(6) m requiring external csf drainage was transferred from ct scanner to bed. During the transfer, the evd pressure cable was caught on pt's bed and pulled evd. While loosening the pressure cable, rn found that the evd bag had dislodged from the evd. Unk pt injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5057516 |
| MDR Report Key | 5187488 |
| Date Received | 2015-10-23 |
| Date of Report | 2015-08-01 |
| Date of Event | 2015-07-16 |
| Date Added to Maude | 2015-10-29 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VENTRICLEAR II VENTRICULAR DRAINAGE COLLECTION SYSTEM |
| Generic Name | MEDTRONIC DUCT EVD |
| Product Code | PCB |
| Date Received | 2015-10-23 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROLOGIC TECHNOLOGIES |
| Manufacturer Address | 123 CEMONA DRIVE GOLETA CA 93117550 US 93117550 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-23 |