MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-04 for PAXGENE? BLOOD RNA TUBE 762165 manufactured by Becton, Dickinson And Company (bd).
[110127680]
Investigation summary bd received samples and photos from the customer facility for investigation. The samples and photos were evaluated and the customer's indicated failure mode for foreign matter with the incident lot was observed. Additionally, retention samples were selected from bd inventory for evaluation and upon completion, the customer's indicated failure mode for foreign matter was not observed. A review of the manufacturing records was completed for the incident lot and no issues were identified. Investigation conclusion: based on evaluation of the customer photos, the customer? S indicated failure mode for foreign matter with the incident lot was observed. Evaluation of the customer samples was conducted and foreign matter was observed. Additionally, evaluation of the retain samples was conducted and foreign matter was not observed. Root cause description: based on the investigation, the most likely root cause was determined to be related to manufacturing process where tube is in between additive filling and evacuation. Rationale: complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored. The bd business team regularly reviews the collected data for identification of emerging trends.
Patient Sequence No: 1, Text Type: N, H10
[110127681]
It was reported that paxgene? Blood rna tube had fm. No serious injury or medical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617032-2018-02088 |
| MDR Report Key | 7567390 |
| Date Received | 2018-06-04 |
| Date of Report | 2018-05-10 |
| Date of Event | 2018-03-13 |
| Date Mfgr Received | 2018-03-13 |
| Device Manufacturer Date | 2017-04-11 |
| Date Added to Maude | 2018-06-04 |
| 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 | 2018-06-04 |
| Returned To Mfg | 2018-03-22 |
| Catalog Number | 762165 |
| Lot Number | 7101799 |
| Device Expiration Date | 2018-11-30 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-06-04 |