MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-06 for BD VACUTAINER? URINALYSIS CONCIAL URINE TUBE NO ADDITIVE 364980 manufactured by Becton, Dickinson & Co. (broken Bow).
[139078319]
Date of event: unknown. (b)(6). 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
[139078320]
It was reported that foreign "spots", similar to the consistency of condensation, were present in 65 of the bd vacutainer? Urinalysis conical urine tubes with no additive, and discovered before use. As reported by the customer, translated from spanish to english, "it presents spots inside like it had any additive, seem to spots of condensation. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1917413-2019-00378 |
| MDR Report Key | 8396327 |
| Date Received | 2019-03-06 |
| Date of Report | 2019-03-25 |
| Date of Event | 2019-02-19 |
| Date Mfgr Received | 2019-02-19 |
| Device Manufacturer Date | 2018-04-09 |
| Date Added to Maude | 2019-03-06 |
| 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 | 0 |
| Brand Name | BD VACUTAINER? URINALYSIS CONCIAL URINE TUBE NO ADDITIVE |
| Generic Name | SPECIMEN TRANSPORT AND STORAGE CONTAINER |
| Product Code | KDT |
| Date Received | 2019-03-06 |
| Returned To Mfg | 2019-03-01 |
| Catalog Number | 364980 |
| Lot Number | 8099568 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-03-06 |