MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2019-01-22 for GUARDIA? ACCESS EMBRYO TRANSFER CATHETER K-JETS-7019 manufactured by Cook Inc.
[133769133]
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
[133769134]
When the embryologist attempted an embryo aspiration under the microscope prior to embryo transfer, she/he noted an unknown substance(s) lodged inside the transfer catheter. The packaging of total 4 devices of the same lot were opened. The same substance(s) was observed on all 4 devices. The catheters were flushed with culture by using a syringe, but the substance(s) was not flushed out. The devices were not used; there was no patient contact. The exact date of event is unknown but it occurred in (b)(6) 2018. The user commented that the substance(s) did not look like dust but more like oil or oily substance. The devices were disposed of in the hospital. Additional information received 22jan2019: another device with a different lot # was used and the procedure was completed. Customer is returning unused devices from the complaint device lot for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-00200 |
| MDR Report Key | 8267824 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2019-01-22 |
| Date of Report | 2019-03-08 |
| Date Mfgr Received | 2019-03-05 |
| Device Manufacturer Date | 2018-07-09 |
| Date Added to Maude | 2019-01-22 |
| 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 |
| 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 | GUARDIA? ACCESS EMBRYO TRANSFER CATHETER |
| Generic Name | MQF CATHETER, ASSISTED REPRODUCTION |
| Product Code | MQF |
| Date Received | 2019-01-22 |
| Returned To Mfg | 2019-01-31 |
| Catalog Number | K-JETS-7019 |
| Lot Number | 8968802 |
| 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 | 2019-01-22 |