MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-03-27 for PIVET GUIDE EMBRYO TRANSFER SET K-PETS-5000 manufactured by Cook Inc.
[103587314]
(b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[103587315]
It was reported two pivot guide embryo transfer sets were opened and oily liquid was found on the inner catheter. After flushing the set, the user found the oily liquid was absorbing into the inner wall of the inner catheter. The distributor in china is returning fifty same lot devices. There were no adverse consequences to the patient as a result of this reported issue. The device did not make contact with the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-00800 |
| MDR Report Key | 7374118 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-03-27 |
| Date of Report | 2018-06-07 |
| Date of Event | 2018-03-19 |
| Date Mfgr Received | 2018-06-01 |
| Device Manufacturer Date | 2017-09-05 |
| Date Added to Maude | 2018-03-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PIVET GUIDE EMBRYO TRANSFER SET |
| Generic Name | MQF CATHETER, ASSISTED REPRODUCTION |
| Product Code | MQF |
| Date Received | 2018-03-27 |
| Catalog Number | K-PETS-5000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-27 |