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 2020-02-12 for BD VACUTAINER? URINE ANALYSIS PRESERVATIVE TUBE 364992 manufactured by Becton, Dickinson & Co. (broken Bow).
[188052667]
There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 9241980. Medical device expiration date: 2021-02-28. Device manufacture date: 2019-08-29. Medical device lot #: 9184874. Medical device expiration date: 2020-12-31. Device manufacture date: 2019-07-03. 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
[188052668]
It was reported that erroneous results were found during use with a bd vacutainer? Urine analysis preservative tube. The following information was provided by the initial reporter, "-it is reported by customer urinalysis instrument alerted crystals being present in specimen. Though upon manual inspection customer confirmed specimen had no crystals present. "notification by urinalysis instrument of presence of crystals; when examined microscopically, no crystals present. Customer uses arkray au4050 for urinalysis testing. They started transferring specimens in the ua department to the uap tube and immediately running them on their instrument. They started receiving crystal notifications, requiring them to review the specimen microscopically, where they then saw no crystals present. " during the survey he stated that the tiger top tubes for urine show crystals in it. That is, it shows falls (+) positive for crystals. " 10 occurrences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1917413-2020-00110 |
| MDR Report Key | 9701807 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-02-12 |
| Date of Report | 2020-01-28 |
| Date of Event | 2020-01-22 |
| Date Mfgr Received | 2020-01-22 |
| Date Added to Maude | 2020-02-12 |
| 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 | 2020-02-12 |
| Catalog Number | 364992 |
| Lot Number | SEE. H.10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2020-02-12 |