MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-08 for BD VACUTAINER? URINE ANALYSIS PRESERVATIVE TUBE 364992 manufactured by Becton, Dickinson & Co. (broken Bow).
[142635758]
Date of event: unknown. The date received by manufacturer has been used for this field. Device expiration date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown.
Patient Sequence No: 1, Text Type: N, H10
[142635759]
It was reported that the bd vacutainer? Urine analysis preservative tube experienced erroneous results. The following information was provided by the customer: material no. : 364992, batch/lot: unknown / not provided. It was reported that the customer is "seeing issues with the preservative tubes and using them for er patients when they are sent immediately and the preservative is not necessary. " customer text: we are currently using the tiger top ua, and grey top with the blue cups. We are looking to see if it is an option for our facility to get a kit with the blue cup (364975), yellow top tube with no additive (364980), and the grey culture tube (364951) in one kit all together. We are seeing issues with the preservative tubes, and using them for er patients when they are sent immediately and the preservative is not necessary.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1917413-2019-01134 |
| MDR Report Key | 8492111 |
| Date Received | 2019-04-08 |
| Date of Report | 2019-04-23 |
| Date of Event | 2019-03-22 |
| Date Mfgr Received | 2019-03-22 |
| Date Added to Maude | 2019-04-08 |
| 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? URINE ANALYSIS PRESERVATIVE TUBE |
| Generic Name | SPECIMEN TRANSPORT AND STORAGE CONTAINER |
| Product Code | KDT |
| Date Received | 2019-04-08 |
| Catalog Number | 364992 |
| Lot Number | UNKNOWN |
| 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 | 2019-04-08 |