MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-06 for BD VACUTAINER? URINE ANALYSIS PRESERVATIVE TUBE UNKNOWN manufactured by Becton Dickinson.
[110453346]
The date received by manufacturer has been used. Medical device manufacturer: unknown. Bd corporate headquarters in (b)(4) has been listed. Manufacturing location: unknown. Bd corporate headquarters in (b)(4)has been listed. Bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited. Additionally, bd was unable to determine the specific lot number associated with this complaint. Therefore, a review of the device history record could not be conducted.
Patient Sequence No: 1, Text Type: N, H10
[110453347]
It was reported that bd vacutainer? Urine analysis preservative tube had "erroneous results" no report of injury or medical intervention. No report of blood exposure to mucous membrane.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2018-01054 |
| MDR Report Key | 7575406 |
| Date Received | 2018-06-06 |
| Date of Report | 2018-05-11 |
| Date of Event | 2016-11-07 |
| Date Mfgr Received | 2016-11-07 |
| Date Added to Maude | 2018-06-06 |
| 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 |
| 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 | 8015652845 |
| Manufacturer G1 | BECTON DICKINSON |
| Manufacturer Street | 1 BECTON DRIVE |
| Manufacturer City | FRANKLIN LAKES NJ 07417 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07417 |
| 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 | KDW |
| Date Received | 2018-06-06 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON |
| Manufacturer Address | 1 BECTON DRIVE FRANKLIN LAKES NJ 07417 US 07417 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-06 |