MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2020-02-26 for PAXGENE? BLOOD RNA TUBE 762165 manufactured by Becton, Dickinson And Company (bd).
[187255894]
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
[187255895]
It was reported that clotting occurred after use with a paxgene? Blood rna tube. The following information was provided by the initial reporter, "customer called for tech support in regards to clotting of specimens. She does have unused tubes to be sent in for investigation. Rna testing was attempted but resulted in abnormally low results for rna. Customer is requesting tech support reach out to her for guidance. Comment type: work performed. Customer is collecting human blood into a sodium heparin tube and transferring to the paxgene rna tube with a syringe and needle. The blood is in the sodium heparin tube for about 24 hours before transferring. When transferred the blood is mixed 6-10 times in the paxgene tube. She states that the clots are pretty solid not microclots. She could not pipette out to do wash step. She does not know why it is happening in some tubes and not others. It is best to draw directly into paxgene tubes and not mix anticoagulant types. " 4 occurrences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617032-2020-00178 |
| MDR Report Key | 9757258 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-02-26 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-02-04 |
| Date Mfgr Received | 2020-02-06 |
| Date Added to Maude | 2020-02-26 |
| 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 | UK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PAXGENE? BLOOD RNA TUBE |
| Generic Name | RNA PREANALYTICAL SYSTEMS |
| Product Code | NTW |
| Date Received | 2020-02-26 |
| Catalog Number | 762165 |
| 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 UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-26 |