MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-02 for PAXGENE? BLOOD RNA TUBE 762165 manufactured by Becton, Dickinson And Company (bd).
[145538997]
A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[145538998]
It was reported that 20 paxgene? Blood rna tubes cracked after use, exposing the staff to blood, though they reportedly wore ppe and were not sent for testing. This complaint was created to capture 1 of 2 related incidents. The following information was provided by the initial reporter: "stated she is experiencing cracking of tubes after use, workers were exposed to blood but no testing was done. " "worker was not sent for testing. Ppe was exposed to blood. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617032-2019-00532 |
| MDR Report Key | 8573700 |
| Date Received | 2019-05-02 |
| Date of Report | 2019-05-23 |
| Date of Event | 2019-04-16 |
| Date Mfgr Received | 2019-04-17 |
| Device Manufacturer Date | 2018-03-22 |
| Date Added to Maude | 2019-05-02 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 8015652341 |
| 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 | 2019-05-02 |
| Catalog Number | 762165 |
| Lot Number | 8081587 |
| Device Expiration Date | 2019-11-30 |
| Device Availability | * |
| Device Age | DA |
| 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 | 2019-05-02 |