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 2018-11-30 for GUARDIA? ACCESS EMBRYO TRANSFER CATHETER K-JETS-7019 manufactured by Cook Inc.
[129582145]
Blank fields on this form indicate the information is unknown or unavailable. Device code: device contaminated during manufacture or shipping is not labeled. 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
[129582146]
It was initially reported, an oily substance was found on the inner portion of the catheter prior to use. Additional information received 30nov2018. Further event clarification was provided. The operator checked the device and the issue was discovered prior to use during the preparation stage. The ivf procedure was completed by changing to another device of the same type. There were no adverse effects to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-03448 |
| MDR Report Key | 8121255 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-11-30 |
| Date of Report | 2019-01-21 |
| Date of Event | 2018-11-09 |
| Date Mfgr Received | 2019-01-18 |
| Device Manufacturer Date | 2018-07-18 |
| Date Added to Maude | 2018-11-30 |
| 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 | 2018-11-30 |
| Returned To Mfg | 2018-12-04 |
| Catalog Number | K-JETS-7019 |
| Lot Number | 8993738 |
| 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 | 2018-11-30 |