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 2020-02-10 for BD VACUTAINER? NO ADDITIVE (Z) PLUS TUBES 366408 manufactured by Becton, Dickinson & Co., (bd).
[184256695]
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
[184256696]
It was reported that sample is "gelling" after spinning with a bd vacutainer? No additive (z) plus tubes. This occurred on 2 separate occasions during use, however, the date/time and or patient information is unknown. The following information was provided by the initial reporter: (2 of 2 complaints). 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 gel.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1024879-2020-00072 |
| MDR Report Key | 9687691 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-02-10 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-01-21 |
| Date Mfgr Received | 2020-01-21 |
| Device Manufacturer Date | 2019-09-17 |
| Date Added to Maude | 2020-02-10 |
| 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 | 2020-02-10 |
| Catalog Number | 366408 |
| Lot Number | 9260637 |
| Device Availability | * |
| Device Age | DA |
| 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 | 2020-02-10 |