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 2020-01-02 for BD VACUTAINER? URINE ANALYSIS PRESERVATIVE TUBE 364992 manufactured by Becton, Dickinson & Co. (broken Bow).
[188062000]
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
[188062001]
It was reported that an unspecified number of bd vacutainer? Urine analysis preservative tubes experienced erroneous results prior to use. The following information was provided by the initial reporter: material no. 364992. Batch no. 9184874. Customer did an evaluation for preservative ua tubes vs non preservative ua tube. Customer is confused about the method comparison. They believe the method comparison should have better correlation. They do not understand the method is a sim-quantitative method.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1917413-2019-02588 |
| MDR Report Key | 9537295 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-01-02 |
| Date of Report | 2020-03-25 |
| Date of Event | 2019-12-10 |
| Date Mfgr Received | 2019-12-13 |
| Device Manufacturer Date | 2019-07-03 |
| Date Added to Maude | 2020-01-02 |
| 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. (BROKEN BOW) |
| Manufacturer Street | 150 SOUTH 1ST AVENUE |
| Manufacturer City | BROKEN BOW NE 68822 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 68822 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD VACUTAINER? URINE ANALYSIS PRESERVATIVE TUBE |
| Generic Name | SPECIMEN TRANSPORT AND STORAGE CONTAINER |
| Product Code | KDT |
| Date Received | 2020-01-02 |
| Catalog Number | 364992 |
| Lot Number | 9184874 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON & CO. (BROKEN BOW) |
| Manufacturer Address | 150 SOUTH 1ST AVENUE BROKEN BOW NE 68822 US 68822 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-02 |