MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2017-08-22 for SOFT-TRANS EMBRYO TRANSFER CATHETER K-SOFT-5000-MO manufactured by Cook Inc.
[83318148]
(b)(4). The event is currently under investigation. A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[83318149]
The cook representative visited the user facility to perform testing of unused soft-trans embryo transfer catheters in stock at the facility in an effort to find a catheter that flushes out yellow media fluid. After testing over 50 unused catheters, one catheter was finally found that the media was flushed through the catheter and came out yellow. This sample and the other devices used during the test were packaged together to return to the manufacturer for further analysis. There was no patient involvement during this testing. The issue of media fluid flushing out "yellow" was previously reported by this facility. However, samples were not provided for analysis. The two previous reports can be found in mfr. Report numbers 1820334-2017-02298 and 1820334-2017-02304.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2017-02680 |
| MDR Report Key | 6811082 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-08-22 |
| Date of Report | 2018-03-23 |
| Date of Event | 2017-08-15 |
| Date Mfgr Received | 2018-02-21 |
| Device Manufacturer Date | 2017-05-24 |
| Date Added to Maude | 2017-08-22 |
| 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 | SOFT-TRANS EMBRYO TRANSFER CATHETER |
| Generic Name | MQF CATHETER, ASSISTED REPRODUCTION |
| Product Code | MQF |
| Date Received | 2017-08-22 |
| Catalog Number | K-SOFT-5000-MO |
| 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 | 2017-08-22 |