MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-05 for STERILE NEURO SPINE PACK SNE3DNSMM8 manufactured by Cardinal Health 200, Llc.
[99022851]
Patient Sequence No: 1, Text Type: N, H10
[99022852]
Neuro spine pack was opened to prepare for surgery. During the count, the scrub tech noted that the spine pack had 11 gauze sponges in the pack instead of the normal 10 count that is on the front of the package. The entire sponge pack was removed from the surgery unit and replaced with a new package of gauze sponges and then counted again.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7240483 |
| MDR Report Key | 7240483 |
| Date Received | 2018-02-05 |
| Date of Report | 2018-02-01 |
| Date of Event | 2018-01-31 |
| Report Date | 2018-02-01 |
| Date Reported to FDA | 2018-02-01 |
| Date Reported to Mfgr | 2018-02-01 |
| Date Added to Maude | 2018-02-05 |
| 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 |
| 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 | STERILE NEURO SPINE PACK |
| Generic Name | NEUROLOGICAL TRAY NEUROLOGICAL TRAY |
| Product Code | LRP |
| Date Received | 2018-02-05 |
| Model Number | SNE3DNSMM8 |
| Catalog Number | SNE3DNSMM8 |
| Lot Number | 802523 |
| Device Expiration Date | 2019-07-01 |
| Device Availability | Y |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200, LLC |
| Manufacturer Address | 1320 DON HASKINS SUITE A EL PASO TX 79936 US 79936 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-05 |