MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-11 for PAXGENE? BLOOD RNA TUBE 762165 manufactured by Becton, Dickinson And Company (bd).
[108146807]
Bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited. Retention samples were selected from bd inventory for evaluation, and the customer's indicated failure mode for (b)(6) was not observed as all samples met specifications. A review of the manufacturing records was completed for the incident lot and no issues were identified.
Patient Sequence No: 1, Text Type: N, H10
[108146808]
It was reported while using the paxgene? Blood rna tube that there were concerns about the integrity of the rna.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617032-2018-01074 |
| MDR Report Key | 7508559 |
| Date Received | 2018-05-11 |
| Date of Report | 2018-04-30 |
| Date of Event | 2017-09-21 |
| Date Mfgr Received | 2017-09-21 |
| Device Manufacturer Date | 2016-07-12 |
| Date Added to Maude | 2018-05-11 |
| 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 AND COMPANY (BD) |
| Manufacturer Street | BELLIVER WAY BELLIVER INDUSTRIAL ESTATE |
| Manufacturer City | PLYMOUTH |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PAXGENE? BLOOD RNA TUBE |
| Generic Name | RNA PREANALYTICAL SYSTEMS |
| Product Code | NTW |
| Date Received | 2018-05-11 |
| Catalog Number | 762165 |
| Lot Number | 6194599 |
| Device Expiration Date | 2018-03-31 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON AND COMPANY (BD) |
| Manufacturer Address | BELLIVER WAY BELLIVER INDUSTRIAL ESTATE PLYMOUTH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-11 |