MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-08 for BD INSTRUMENT SEDI-40 361546 manufactured by Becton Dickinson.
[94987191]
There are multiple bd locations where this unspecified bd device may have been manufactured. A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured. Medical device expiration date: unknown. Device manufacture date: unknown. Results: bd received 1 instrument returned from the customer facility for investigation. The returned unit was returned to the manufacturer for service, and it was observed that the tube cover was broken. The cover was replaced by the manufacturer and returned to the customer. Conclusion: based on the investigation, a root cause could not be determined within the scope of this evaluation. Bd was able to duplicate or confirm the customer? S indicated failure mode.
Patient Sequence No: 1, Text Type: N, H10
[94987192]
It was reported that the bd instrument sedi-40 tube cover was broken. No serious injury or medical intervention reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2017-00367 |
| MDR Report Key | 7100309 |
| Date Received | 2017-12-08 |
| Date of Report | 2017-11-21 |
| Date of Event | 2017-06-07 |
| Date Mfgr Received | 2017-06-07 |
| Date Added to Maude | 2017-12-08 |
| 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 | 2017-12-08 |
| Returned To Mfg | 2017-07-19 |
| 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 | 2017-12-08 |