MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-05 for PAXGENE? BLOOD RNA TUBE 762165 manufactured by Becton, Dickinson And Company (bd).
[142413818]
Investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited. Retention samples were selected from bd inventory for evaluation/testing and upon completion, no issues were observed as all samples met specifications. A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformance during manufacturing of the product. Investigation conclusion: based on evaluation of the retain samples, the customer? S indicated failure mode with the incident lot was not observed as all samples met the required specifications. Root cause description: based on the investigation, a root cause could not be determined. The retain product was found to be in conformance and meet release specifications. 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
[142413819]
It was reported that stopper came off of the paxgene? Blood rna tube while the nurse was releasing it from a rubber band, and the contents splashed onto one of the nurse's chest and neck area. This brought on "an immediate burning sensation", and "necessary steps to resolve the incident" were taken, but there were no reports of serious injury or medical intervention. It was also stated the "rn was wearing gloves and goggles" when the event took place. The following information was provided by the initial reporter: "it was reported that the top of the tube came off as the nurse was releasing it from a rubber band. The tube contents splashed onto one of our cru nurses and we completed an internal incident report. I need to let you know of a defect w/a supplied pax gene tube from last weekend. On (b)(6) 2019, the top of the tube came off as the nurse was releasing it from a rubber band. The tube contents splashed onto one of our cru nurses and we completed an internal incident report. The rn reported that the liquid splash area had an immediate burning sensation and the nurse took the necessary steps to resolve the safety incident. The rn was wearing gloves and goggles. " there are two paxgene tubes collected at one time so it looks like they bind them together with the rubber band. "i was taking off the rubber band on the tubes and one of the paxgene tops came off and splashed onto my chest/neck area. Instant burning sensation was felt, i immediately washed off the area, burning sensation subsided. We bind the two paxgenes together with the rubber band. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617032-2019-00397 |
| MDR Report Key | 8488323 |
| Date Received | 2019-04-05 |
| Date of Report | 2019-03-28 |
| Date of Event | 2019-03-09 |
| Date Mfgr Received | 2019-03-21 |
| Device Manufacturer Date | 2018-01-16 |
| Date Added to Maude | 2019-04-05 |
| 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 | 2019-04-05 |
| Catalog Number | 762165 |
| Lot Number | 8016990 |
| Device Expiration Date | 2019-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 |
|---|---|---|---|
| 0 | 0 | 1. Other | 2019-04-05 |