MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-09 for BD SEDI-40 361546 manufactured by Becton Dickinson.
[108248128]
Medical device lot #: unknown. Medical device expiration date: unknown. Device manufacture date: unknown. (b)(6). Bd received samples from the customer facility for investigation. The samples were evaluated and the customer's indicated failure mode for bd sedi-40 with the incident lot was observed. However, bd was unable to determine the specific lot number associated with this complaint. Therefore, a review of the device history record could not be conducted.
Patient Sequence No: 1, Text Type: N, H10
[108248129]
It was reported that bd sedi-40 broke while mixing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2018-00545 |
| MDR Report Key | 7499470 |
| Date Received | 2018-05-09 |
| Date of Report | 2018-04-24 |
| Date of Event | 2016-12-30 |
| Date Mfgr Received | 2017-01-02 |
| Date Added to Maude | 2018-05-09 |
| 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 |
| 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 | 2018-05-09 |
| Returned To Mfg | 2017-01-02 |
| Catalog Number | 361546 |
| Lot Number | UNKNOWN |
| Device Availability | R |
| 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 | 2018-05-09 |