MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-19 for COOK ECHOTIP AMNIOCENTESIS NEEDLE J-DAN-201501 manufactured by Cook Inc.
[95534826]
(b)(4). The event is currently under investigation. A follow up report will be submitted upon receipt of additional information or completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[95534827]
The user facility reported during an amniocentesis procedure, the cook echo tip amniocentesis needle could not be seen under the ultrasound during the procedure. Additional information that was received was the needle was more flexible and not visible. There was no report of any adverse effects or consequences to the patient due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2017-04338 |
| MDR Report Key | 7132627 |
| Date Received | 2017-12-19 |
| Date of Report | 2018-03-07 |
| Date of Event | 2017-11-09 |
| Date Mfgr Received | 2018-02-22 |
| Device Manufacturer Date | 2017-04-28 |
| Date Added to Maude | 2017-12-19 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COOK ECHOTIP AMNIOCENTESIS NEEDLE |
| Generic Name | HIO SAMPLER, AMNIOTIC FLUID (AMNIOCENTESIS TRAY) |
| Product Code | HIO |
| Date Received | 2017-12-19 |
| Catalog Number | J-DAN-201501 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-12-19 |