MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-01 for BD SEDI-40 361546 manufactured by Becton, Dickinson And Company (bd).
[107355550]
Expiration date unknown, lot number unknown, unique identifier (udi) # is unknown, date device returned to manufacturer is unknown, the date supplied is the date of investigation. (b)(6). Manufacture date unknown. Bd received the instrument from the customer facility for investigation. The instrument was evaluated and the customer's indicated failure mode for 91818 with the incident lot was observed.
Patient Sequence No: 1, Text Type: N, H10
[107355631]
It was reported that while using the bd sedi-40, the instrument was not working properly. The reporter stated, "after mixing samples it prints wrong information without results nor ids.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617032-2018-00888 |
| MDR Report Key | 7477812 |
| Date Received | 2018-05-01 |
| Date of Report | 2018-04-25 |
| Date of Event | 2017-05-22 |
| Date Mfgr Received | 2017-05-22 |
| Date Added to Maude | 2018-05-01 |
| 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 | BDX BRETT WILKO |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652845 |
| Manufacturer G1 | BECTON, DICKINSON AND COMPANY (BD) |
| Manufacturer Street | BELLIVER WAY BELLIVER INDUSTRIAL ESTATE |
| Manufacturer City | PLYMOUTH |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD SEDI-40 |
| Generic Name | ESR INSTRUMENT |
| Product Code | GHC |
| Date Received | 2018-05-01 |
| Returned To Mfg | 2017-06-19 |
| Catalog Number | 361546 |
| Lot Number | UNKNOWN |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON AND COMPANY (BD) |
| Manufacturer Address | BELLIVER WAY BELLIVER INDUSTRIAL ESTATE PLYMOUTH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-01 |