MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-20 for BD SEDI-40 361546 manufactured by Becton Dickinson.
[106398692]
Medical device manufacturer: unknown. Device expiration date: unknown. Returned to manufacture on: unknown. The investigation date has been used in this field. (b)(6). Device manufacture date: unknown. Bd received samples from the customer facility for investigation. The samples were evaluated and the customer's indicated failure mode for 72042 with the incident lot was observed. Although the cause of the malfunction was identified as a loose cable, the reason as to why the cable was loose could not be established. Based on an evaluation of severity and frequency it was determined that no corrective action is required at this time. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored. Our business team regularly reviews the collected data for monitoring of current trends.
Patient Sequence No: 1, Text Type: N, H10
[106398693]
It was reported that bd sedi-40 "sedi-361546-broken/damaged. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2018-00520 |
| MDR Report Key | 7447808 |
| Date Received | 2018-04-20 |
| Date of Report | 2018-04-18 |
| Date of Event | 2016-12-06 |
| Date Mfgr Received | 2016-12-06 |
| Date Added to Maude | 2018-04-20 |
| 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 | 2018-04-20 |
| Returned To Mfg | 2017-02-06 |
| Catalog Number | 361546 |
| Lot Number | 15-42012 |
| 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 | 2018-04-20 |