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 2019-10-30 for GUARDIA ACCESS NANO EMBRYO TRANSFER CATHETER G24216 K-JETS-551910-S manufactured by Cook Inc.
[164318619]
Pma/510k #: k172051. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[164318620]
It was reported, prior to an unspecified procedure using a guardia access nano embryo transfer catheter, the operator checked the device and noted an unknown oily liquid on the transfer catheter. The procedure was completed by using another same type device. No adverse events have been reported as a result of the alleged malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-02728 |
| MDR Report Key | 9256561 |
| Report Source | DISTRIBUTOR,FOREIGN,OTHER,USE |
| Date Received | 2019-10-30 |
| Date of Report | 2019-10-30 |
| Date of Event | 2019-09-30 |
| Date Mfgr Received | 2019-10-29 |
| Device Manufacturer Date | 2019-02-08 |
| Date Added to Maude | 2019-10-30 |
| 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 NANO EMBRYO TRANSFER CATHETER |
| Generic Name | MQF CATHETER, ASSISTED REPRODUCTION |
| Product Code | MQF |
| Date Received | 2019-10-30 |
| Model Number | G24216 |
| Catalog Number | K-JETS-551910-S |
| Lot Number | NS9433397 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-10-30 |