MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-19 for ANORA COLLECTION KIT ANORA FRESH 3927289-2-POC manufactured by Natera.
[97974459]
Upon opening the anora, natera, single nucleotide polymorphism (snp) microarray chromosome analysis collection kit in the operating room, i noticed the specimen container inside the kit did not have nss solution in it. It appeared the solution had leaked ut because there were still droplets of a solution inside the container. I decided to discard the kit and use a new natera kit as i wasn't sure if the container integrity had been compromised. Miscarriage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5074677 |
| MDR Report Key | 7208997 |
| Date Received | 2018-01-19 |
| Date of Report | 2017-12-21 |
| Date of Event | 2017-12-20 |
| Date Added to Maude | 2018-01-22 |
| 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 |
| 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 | ANORA COLLECTION KIT |
| Generic Name | KIT, CULTURE, CHROMOSOME. |
| Product Code | KIQ |
| Date Received | 2018-01-19 |
| Model Number | ANORA FRESH |
| Catalog Number | 3927289-2-POC |
| Lot Number | E08118,7067962,F013019,1864553 |
| Device Expiration Date | 2018-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATERA |
| Manufacturer Address | AUSTIN TX 78753 US 78753 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-19 |