MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-29 for PAXGENE? BLOOD DNA TUBE 761165 manufactured by Becton, Dickinson And Company (bd).
[140935265]
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, the customer's indicated failure mode for underfill was not observed. 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. Bd has initiated further investigation relating to this issue through a capa. The investigation is still on-going and improvements will be made as the potential causes of this issue are identified. Capa #: pr# (b)(4). Investigation conclusion : based on evaluation of the retain samples, the customer? S indicated failure mode for underfill with the incident lot was not observed. Further investigation has been initiated through a capa. The investigation is still on-going and improvements will be made as the potential causes are identified. Root cause description : a capa has been initiated to document further investigation and root cause analysis relating to this issue. The investigation is currently on-going and will be updated as the potential root cause(s) are identified.
Patient Sequence No: 1, Text Type: N, H10
[140935266]
It was reported that the customer used a bd paxgene? Blood dna tube to draw blood, and she was only able to draw 1ml out of 2. 5 ml. Customer? S verbatim:? Research study and the tubes are under filling. She was only able to draw 1ml out of 2. 5ml's. ".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617032-2019-00366 |
| MDR Report Key | 8465879 |
| Date Received | 2019-03-29 |
| Date of Report | 2019-04-01 |
| Date of Event | 2019-03-07 |
| Date Mfgr Received | 2019-03-07 |
| Device Manufacturer Date | 2018-04-18 |
| Date Added to Maude | 2019-03-29 |
| 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 DNA TUBE |
| Generic Name | BLOOD SPECIMEN COLLECTION DEVICE |
| Product Code | PJE |
| Date Received | 2019-03-29 |
| Catalog Number | 761165 |
| Lot Number | 8108757 |
| Device Availability | N |
| 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 | 2019-03-29 |