MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2018-06-15 for BD SEDI-40 361546 manufactured by Becton Dickinson.
[111452691]
Medical device expiration date: unknown. Device manufacture date: unknown. In this mdr, bd corporate headquarters in (b)(4) has been listed as (b)(4) is an oem manufacturing site. Returned to manufacturer on: used date of repair in attachments. Bd received samples from the customer facility for investigation. The samples were evaluated and the customer's indicated failure mode with the incident lot was not observed.
Patient Sequence No: 1, Text Type: N, H10
[111452692]
It was reported that bd sedi-40 gave erroneous coagulation results. No report of medical intervention or serious injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2018-01212 |
| MDR Report Key | 7606001 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2018-06-15 |
| Date of Report | 2018-05-30 |
| Date of Event | 2016-07-07 |
| Date Mfgr Received | 2016-07-11 |
| Date Added to Maude | 2018-06-15 |
| 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 | 3 |
| Brand Name | BD SEDI-40 |
| Generic Name | ESR INSTRUMENT. |
| Product Code | GHC |
| Date Received | 2018-06-15 |
| Returned To Mfg | 2016-07-20 |
| 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 | 2018-06-15 |