MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-01 for PAXGENE? BLOOD RNA TUBE 762165 manufactured by Becton, Dickinson And Company (bd).
[137939396]
Date of event: unknown. The date received by manufacturer has been used for this field. There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 4265247. Medical device expiration date: 2016-03-31. Device manufacture date: 2014-09-22. Medical device lot #: 6014599. Medical device expiration date: 2017-07-31. Device manufacture date: 2016-01-14. (b)(6). 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
[137939397]
It was reported that the paxgene? Blood rna tube bottoms broke during the extraction and after the first centrifugation, having been used to draw blood in 2015 and then stored in "-80? C" temperatures for approximately three years. Lot #'s 4265247 and 6014599 were reported to have been involved in this event, but it is unknown how many occurrences happened within each lot. As reported by the customer, translated from french to english, "we wanted to report problems with paxgene tubes, ref (b)(4). These tubes were used to draw in 2015, and then stored at -80? C until 2018. During extraction, the first centrifugation, the bottom of the tubes broke. The lot numbers are: lot 4265247 and lot 6014599".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617032-2019-00245 |
| MDR Report Key | 8383590 |
| Date Received | 2019-03-01 |
| Date of Report | 2019-03-26 |
| Date of Event | 2019-02-14 |
| Date Mfgr Received | 2019-02-14 |
| Date Added to Maude | 2019-03-01 |
| 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 | 2019-03-01 |
| Catalog Number | 762165 |
| Lot Number | SEE SECTION H.10. |
| 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 | 2019-03-01 |