MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-04 for BD INSTRUMENT SEDI-40 361546 manufactured by Becton Dickinson.
[94409365]
Medical device lot # unknown. Medical device expiration date: unknown. (b)(6). Device manufacture date: unknown. Results: a sample was returned for evaluation, the instrument was tested and was found to be incorrectly calibrated? This was corrected and a new fan installed as the existing one was noisy. Conclusion: root cause is indeterminate.
Patient Sequence No: 1, Text Type: N, H10
[94409366]
It was reported that bd instrument sedi-40 had llo messages and inadequate filling upon use. No medical intervention or injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2017-00296 |
| MDR Report Key | 7081305 |
| Date Received | 2017-12-04 |
| Date of Report | 2017-11-14 |
| Date of Event | 2017-04-05 |
| Date Mfgr Received | 2017-04-05 |
| Date Added to Maude | 2017-12-04 |
| 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 INSTRUMENT SEDI-40 |
| Generic Name | SEDIMENTION INSTRUMENT |
| Product Code | GHC |
| Date Received | 2017-12-04 |
| Returned To Mfg | 2017-04-26 |
| 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 | 2017-12-04 |