MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2018-12-21 for PAXGENE? BLOOD RNA TUBE 762174 manufactured by Becton, Dickinson And Company (bd).
[131333985]
Date of event: unknown. Device expiration date: unknown. Device manufacture date: unknown. There are multiple bd locations where this device may have been manufactured. Once we have ascertained where the device was manufactured a supplemental report will filed. 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
[131333986]
It was reported that the secondary hemogard closures are not fitting into the paxgene? Blood rna tube.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2018-01836 |
| MDR Report Key | 8191639 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2018-12-21 |
| Date of Report | 2019-01-08 |
| Date of Event | 2018-12-07 |
| Date Mfgr Received | 2018-12-07 |
| Date Added to Maude | 2018-12-21 |
| 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 | 8015652845 |
| Manufacturer G1 | BECTON, DICKINSON AND COMPANY (BD) |
| Manufacturer Street | BELLIVER WAY BELLIVER INDUSTRIAL ESTATE |
| Manufacturer City | PLYMOUTH NJ 07417 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07417 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PAXGENE? BLOOD RNA TUBE |
| Generic Name | RNA BLOOD COLLECTION TUBES |
| Product Code | NTW |
| Date Received | 2018-12-21 |
| Catalog Number | 762174 |
| Lot Number | UNKNOWN |
| 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 NJ 07417 US 07417 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-21 |