MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,other,use report with the FDA on 2018-01-16 for PIVET GUIDE EMBRYO TRANSFER SET K-PETS-5000 manufactured by Cook Inc.
[97574488]
(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
[97574489]
It was reported prior to patient contact, an unknown oily liquid was found in the inner catheter of the pivet guide embryo transfer set. After flushing the device, the user still found the oily liquid adsorbed on the inner wall of the inner catheter. No patient contact. No adverse effects or consequences were reported to the patient due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-00095 |
| MDR Report Key | 7192907 |
| Report Source | DISTRIBUTOR,FOREIGN,OTHER,USE |
| Date Received | 2018-01-16 |
| Date of Report | 2018-09-13 |
| Date of Event | 2018-01-07 |
| Date Mfgr Received | 2018-09-12 |
| Device Manufacturer Date | 2017-07-25 |
| Date Added to Maude | 2018-01-16 |
| 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 |
| Manufacturer G1 | COOK INC. |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| 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 | 2018-01-16 |
| Returned To Mfg | 2018-01-30 |
| Catalog Number | K-PETS-5000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2018-01-16 |