MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-08-10 for AMNISURE * manufactured by Amnisure.
[15539966]
The nurse was preparing to perform the test and observed that the vial was empty. It should have contained the diluent. The nurse obtained another test kit (same manufacturer and lot number) which had a vial that contained diluent. This has been a recurring problem. We have been in communication with the vendor. The vendor indicated that they have made a change in manufacturing and now the vial is sealed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210985 |
| MDR Report Key | 2210985 |
| Date Received | 2011-08-10 |
| Date of Report | 2011-08-10 |
| Date of Event | 2011-08-09 |
| Report Date | 2011-08-10 |
| Date Reported to FDA | 2011-08-10 |
| Date Added to Maude | 2011-08-12 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMNISURE |
| Generic Name | RAPID FETAL MEMBRANE RUPTURE TEST KIT |
| Product Code | NQM |
| Date Received | 2011-08-10 |
| Model Number | AMNISURE |
| Catalog Number | * |
| Lot Number | A0012 |
| ID Number | * |
| Operator | NURSE |
| Device Age | 0 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMNISURE |
| Manufacturer Address | 24 SCHOOL ST 6TH FLOOR BOSTON MA 02108511 US 02108 5113 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-10 |