MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-16 for SITE RITE 8 ULTRASOUND SYSTEM 20MM CUE LINEAR PROBE 9770603 manufactured by Bard Access Systems.
[145355966]
The manufacturer has received the sample and will be evaluated. Results are expected soon. A lot history review (lhr) review is not possible, as the device is manufactured using a unique serial number and not by lot number. A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
Patient Sequence No: 1, Text Type: N, H10
[145355967]
Per tm: poor image quality. 2 blackout areas on the screen.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2019-01410 |
| MDR Report Key | 8617316 |
| Date Received | 2019-05-16 |
| Date of Report | 2019-08-09 |
| Date Mfgr Received | 2019-07-15 |
| Date Added to Maude | 2019-05-16 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SHELLY GILBERT |
| Manufacturer Street | 605 N. 5600 W. |
| Manufacturer City | SALT LAKE CITY UT 84116 |
| Manufacturer Country | US |
| Manufacturer Postal | 84116 |
| Manufacturer Phone | 8015225640 |
| Manufacturer G1 | BARD MEDICAL DIVISION |
| Manufacturer Street | 8195 INDUSTRIAL BOULEVARD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30014 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SITE RITE 8 ULTRASOUND SYSTEM 20MM CUE LINEAR PROBE |
| Generic Name | SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC |
| Product Code | IYO |
| Date Received | 2019-05-16 |
| Returned To Mfg | 2019-05-01 |
| Model Number | 9770603 |
| Catalog Number | 9770603 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD ACCESS SYSTEMS |
| Manufacturer Address | 605 N. 5600 W. SALT LAKE CITY UT 84116 US 84116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-16 |