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 2020-02-11 for BD VACUTAINER? NO ADDITIVE (Z) PLUS TUBES 366408 manufactured by Becton, Dickinson & Co., (bd).
[186278320]
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
[186278321]
It was reported that erroneous results occurred during use with a bd vacutainer? No additive (z) plus tubes. The following information was provided by the initial reporter, "customer called in to report that the red top tubes are gelling. She stated that they spin them down and they are well separated however when they transfer them to a tube for send out they will not stay liquid, they have to spin them down 3x to get them to not gell. She stated this occurred yesterday 1 time and twice today. " 1 of 2 complaints.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1024879-2020-00079 |
| MDR Report Key | 9694109 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-02-11 |
| Date of Report | 2020-01-22 |
| Date of Event | 2020-01-20 |
| Date Mfgr Received | 2020-01-21 |
| Device Manufacturer Date | 2019-09-17 |
| Date Added to Maude | 2020-02-11 |
| 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 & CO., (BD) |
| Manufacturer Street | 1575 AIRPORT ROAD |
| Manufacturer City | SUMTER SC 29153 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 29153 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD VACUTAINER? NO ADDITIVE (Z) PLUS TUBES |
| Generic Name | SPECIMEN TRANSPORT AND STORAGE CONTAINER |
| Product Code | FMH |
| Date Received | 2020-02-11 |
| Catalog Number | 366408 |
| Lot Number | 9260637 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON & CO., (BD) |
| Manufacturer Address | 1575 AIRPORT ROAD SUMTER SC 29153 US 29153 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-11 |