MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-27 for BD SEDI-40? 361546 manufactured by Becton Dickinson.
[122163630]
Date of event: unknown. The date received by manufacturer has been used for this field. (b)(4). (b)(6). A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[122163631]
It was reported that bd sedi-40? Produced an error message and would not function. No serious injury or medical intervention was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2018-01474 |
| MDR Report Key | 7915729 |
| Date Received | 2018-09-27 |
| Date of Report | 2018-09-27 |
| Date of Event | 2018-08-24 |
| Date Mfgr Received | 2018-08-24 |
| Date Added to Maude | 2018-09-27 |
| 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 | 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 |
| Manufacturer Street | 1 BECTON DRIVE |
| Manufacturer City | FRANKLIN LAKES NJ 07417 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07417 |
| 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 | 2018-09-27 |
| Catalog Number | 361546 |
| Lot Number | N/A |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON |
| Manufacturer Address | 1 BECTON DRIVE FRANKLIN LAKES NJ 07417 US 07417 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-27 |