MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-07 for BD SEDI-40 36154608 manufactured by Becton Dickinson.
[107722001]
Medical device lot #: unknown. Medical device expiration date: unknown. Medical device model #: unknown. Device manufacture date: unknown. Date device returned to manufacturer is unknown. The date of investigation was used. Bd received the sample from the customer facility for investigation. The samples was evaluated and the customer's indicated failure mode for broken hardware 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
[107722002]
It was reported that the bd sedi-40 was broken and would not hold the tubes tightly enough.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2018-00726 |
| MDR Report Key | 7493026 |
| Date Received | 2018-05-07 |
| Date of Report | 2018-04-27 |
| Date of Event | 2017-08-08 |
| Date Mfgr Received | 2017-08-23 |
| Date Added to Maude | 2018-05-07 |
| 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 | 2018-05-07 |
| Returned To Mfg | 2017-12-19 |
| Catalog Number | 36154608 |
| 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 | 2018-05-07 |