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 2018-09-04 for GUARDIA? ACCESS EMBRYO TRANSFER CATHETER K-JETS-7019 manufactured by Cook Inc.
[119533217]
Occupation: non-healthcare professional. (b)(4). 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
[119533218]
It was reported, the user checked the integrity of the guardia? Access embryo transfer catheter before use, and discovered there is an oily substance inside of the catheter. As reported, another 11 devices were opened and found to have an oily substance inside as well. Another same product was opened to complete the procedure. None of the devices with oil substance came in contact with the patient. No adverse events have been reported as a result of the alleged malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-02562 |
| MDR Report Key | 7843116 |
| Report Source | DISTRIBUTOR,FOREIGN,OTHER,USE |
| Date Received | 2018-09-04 |
| Date of Report | 2018-09-24 |
| Date of Event | 2018-07-30 |
| Date Mfgr Received | 2018-08-29 |
| Device Manufacturer Date | 2018-02-09 |
| Date Added to Maude | 2018-09-04 |
| 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 | 2018-09-04 |
| Returned To Mfg | 2018-08-30 |
| Catalog Number | K-JETS-7019 |
| Lot Number | 8536242 |
| 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 | 2018-09-04 |