MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-03-24 for AMNISURE * manufactured by Amnisure International Llc.
[1914340]
Nurse was attempting to test for fetal membrane rupture using amnisure test kit. Vial should have contained solvent was empty. Nurse obtained another amnisure test kit from the same box as first kit (lot number the same) and successfully completed test. There was slight delay in testing. ====================== manufacturer response for fetal membrane rupture test kit, amnisure======================filed complaint by telephone; company acknowledged that this issue has arisen from time to time. They are in process of implementing a change to a different vial that will provide better seal. ============== reporter responses ======================reporter indicated the kit is individually packaged and sealed in a plastic bag. No moisture or moisture stains were noted. The user facility had a similar incident about two months ago. No visual discrepancies were noted on the vial. Manufacturer representative admitted to the user facility they are aware of the problem and they are working together with fda on a new vial.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2033245 |
| MDR Report Key | 2033245 |
| Date Received | 2011-03-24 |
| Date of Report | 2011-03-24 |
| Date of Event | 2011-03-23 |
| Report Date | 2011-03-24 |
| Date Reported to FDA | 2011-03-24 |
| Date Added to Maude | 2011-03-30 |
| 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 | FETAL MEMBRANE RUPTURE TEST KIT |
| Product Code | NQM |
| Date Received | 2011-03-24 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | A0012 |
| ID Number | * |
| Operator | NURSE |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMNISURE INTERNATIONAL LLC |
| Manufacturer Address | 24 SCHOOL ST 6TH FLOOR BOSTON MA 02108 US 02108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-24 |