MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,other report with the FDA on 2019-05-13 for GUARDIA? ACCESS EMBRYO TRANSFER CATHETER G34783 K-JETS-7019 manufactured by Cook Inc.
[145510870]
(b)(6). Occupation: non-healthcare professional. 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
[145510871]
It is reported while preparing for an unspecified procedure using a guardia? Access embryo transfer catheter, "the operator checked the product and found unknown oil liquid inside the transfer catheter". It is unknown how the procedure was completed after the issue was discovered. No adverse effects to the patient have been reported as a result of this alleged product malfunction. Additional details have been requested regarding the patient and event. At the time of this report, no additional information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-01117 |
| MDR Report Key | 8606130 |
| Report Source | DISTRIBUTOR,FOREIGN,OTHER |
| Date Received | 2019-05-13 |
| Date of Report | 2019-06-28 |
| Date of Event | 2019-03-30 |
| Date Mfgr Received | 2019-06-05 |
| Device Manufacturer Date | 2018-06-18 |
| Date Added to Maude | 2019-05-13 |
| 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 | 2019-05-13 |
| Returned To Mfg | 2019-05-15 |
| Model Number | G34783 |
| Catalog Number | K-JETS-7019 |
| Lot Number | 8895872 |
| 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 | 2019-05-13 |