MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-21 for PAXGENE? BLOOD DNA TUBE 761165 manufactured by Becton, Dickinson And Company (bd).
[146514508]
(b)(6). There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 9008512, medical device expiration date: 2020-01-31, device manufacture date: 2019-01-08. Medical device lot #: 8108757, medical device expiration date: 2019-05-31, device manufacture date: 2018-04-18. Device evaluated by mfr: 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
[146514509]
It was reported that 200 paxgene? Blood dna tubes from lot # 9008512, and an unspecified number of tubes from lot # 8108757 underfilled during use. The following information was provided by the initial reporter: "underfill of paxgene dna tubes. Customer uses paxgene dna tubes 761165. Has two separate lots and with both of these they experience significant underfill of the tubes. Lot numbers: 8108757 exp 31. 05. 2019, 9008512 exp 31. 01. 2020. At the same time they also use paxgene rna tubes that show no problems. Both tubes are filled at same time point with same needle and holder. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617032-2019-00609 |
| MDR Report Key | 8629111 |
| Date Received | 2019-05-21 |
| Date of Report | 2019-06-17 |
| Date of Event | 2019-05-01 |
| Date Mfgr Received | 2019-05-03 |
| Date Added to Maude | 2019-05-21 |
| 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 | 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 | 2019-05-21 |
| Returned To Mfg | 2019-05-21 |
| Catalog Number | 761165 |
| Lot Number | SEE SECTION H.10. |
| Device Availability | R |
| Device Age | DA |
| 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 | 2019-05-21 |