MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-26 for NEURO SUCTION TUBING 30-INCH NST030/20 manufactured by Bioseal.
[58381194]
Patient Sequence No: 1, Text Type: N, H10
[58381195]
A yellow (b)(6) sticker was found inside the neuro suction tubing package. The (b)(6) sticker could not be seen through package. When the circulator opened package, it was discovered before it hit the sterile field. No patient was involved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6056935 |
| MDR Report Key | 6056935 |
| Date Received | 2016-10-26 |
| Date of Report | 2016-09-12 |
| Date of Event | 2016-09-08 |
| Report Date | 2016-09-12 |
| Date Reported to FDA | 2016-09-12 |
| Date Reported to Mfgr | 2016-09-12 |
| Date Added to Maude | 2016-10-26 |
| 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 | NEURO SUCTION TUBING |
| Generic Name | TUBING, NONINVASIVE |
| Product Code | GAZ |
| Date Received | 2016-10-26 |
| Model Number | 30-INCH |
| Catalog Number | NST030/20 |
| Lot Number | 1191 |
| Operator | NURSE |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOSEAL |
| Manufacturer Address | 167 WEST ORANGETHORPE AVE. PLACENTIA CA 92870 US 92870 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-26 |