MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-12 for BD SEDI-40 361546 manufactured by Becton Dickinson.
[111210334]
In this mdr, bd corporate headquarters in (b)(4) has been listed as (b)(4) is an oem manufacturing site. Medical device expiration date: unknown. Device manufacture date: unknown. Date device returned to manufacturer is unknown. Investigation summary: the customer's instrument was returned to the manufacturer for service. The instrument was evaluated and the customer's indicated failure mode for llo and lhi flagging was not observed. Evaluation of the customer unit was performed and the indicated failure mode could not be replicated. Investigation conclusion: based on evaluation of the customer's instrument, the customer? S indicated failure mode for llo and lhi flagging with the unit was not observed. Root cause description: based on the investigation, a root cause could not be determined. The product was found to be in conformance and meet release specifications. Rationale: complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored. The bd business team regularly reviews the collected data for identification of emerging trends.
Patient Sequence No: 1, Text Type: N, H10
[111210335]
It was reported that bd sedi-40 gives a lot of llo and lhi messages. No serious injury or medical intervention reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2018-01230 |
| MDR Report Key | 7592025 |
| Date Received | 2018-06-12 |
| Date of Report | 2018-05-21 |
| Date of Event | 2017-11-20 |
| Date Mfgr Received | 2017-11-20 |
| Date Added to Maude | 2018-06-12 |
| 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 | 2018-06-12 |
| Returned To Mfg | 2018-03-21 |
| Catalog Number | 361546 |
| Lot Number | SN 00219 |
| 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 | 2018-06-12 |