MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-06 for MEDTRONIC DUET EVD UNK manufactured by Medtronic Neurological Technologies.
[20033825]
A (b)(6) female admitted with stroke symptoms and ivh on (b)(6) 2015. Taken to operating room on (b)(6) 2015 for ventricular drain insertion with csf fluid collection system attached. On (b)(6) 2015, rn was doing a routine initial evd bag change. Difficulty was encountered when rn attempted to disconnect the bag from the drip chamber at the luer lock site. Luer lock became disconnected at the top of the device instead of at the bottom. Luer lock was reattached to the drip chamber and the fluid in the bag was removed from the bottom access port with a syringe. Dates of use: (b)(6) 2015. Diagnosis or reason for use: stroke.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5043912 |
| MDR Report Key | 4905740 |
| Date Received | 2015-07-06 |
| Date of Report | 2015-06-22 |
| Date of Event | 2015-05-24 |
| Date Added to Maude | 2015-07-13 |
| 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 DUET EVD |
| Generic Name | VENTRICLEAR II VENTRICULAR DRAINAGE COLLECTION SYSTEM |
| Product Code | PCB |
| Date Received | 2015-07-06 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROLOGICAL TECHNOLOGIES |
| Manufacturer Address | 123 CEMONA DR. GOLETO CA 93117550 US 93117 550 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-06 |