MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-12 for CARDINAL HEALTH ? CRANIOTOMY TRAY SNE13CRMG5 manufactured by Cardinal Health 200, Llc.
[130046232]
Operating room (or) circulating nurse opened 3-0 vicryl suture pop-offs that were in the craniotomy pack, and found an extra needle in it. It did not have any strands attached. Craniotomy pack catalog sne13crmg5 lot# 994263 exp. 06/01/2020. Manufacturer response for neurological tray, cardinal health (per site reporter). Unknown
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8154677 |
| MDR Report Key | 8154677 |
| Date Received | 2018-12-12 |
| Date of Report | 2018-12-02 |
| Date of Event | 2018-10-31 |
| Report Date | 2018-12-02 |
| Date Reported to FDA | 2018-12-02 |
| Date Reported to Mfgr | 2018-12-12 |
| Date Added to Maude | 2018-12-12 |
| 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 | 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 | CARDINAL HEALTH ? CRANIOTOMY TRAY |
| Generic Name | NEUROLOGICAL TRAY |
| Product Code | OJG |
| Date Received | 2018-12-12 |
| Model Number | SNE13CRMG5 |
| Catalog Number | SNE13CRMG5 |
| Lot Number | 994263 |
| Device Availability | N |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200, LLC |
| Manufacturer Address | 3651 BIRCHWOOD DRIVE WAUKEGAN IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-12 |