MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-20 for BD VACUTAINER? PLUS PLASTIC TRANSPORT KIT FOR UA CHEMISTY URINE TESTING 364990 manufactured by Becton, Dickinson & Co. (broken Bow).
[139446851]
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[139446852]
It was reported that bd vacutainer? Plus plastic transport kit for ua chemistry urine testing straw separated from the holder. No serious injury or medical intervention was reported. Verbatim: "material no. 364990, lot no. 8179594. Customer reports urine straw separated from holder when pressure was applied. Customer stated, - "i am inquiring if you've heard of any other instances of the urinalysis transfer straw kit coming apart when applying pressure to the needle from the urinalysis plus urine tube? We had an occurrence last week that the needle and straw came apart from the holder and fell into the urine cup where the needle was then just sticking up out of the urine cup. No exposure occurred, but she did bring it to my attention that she had never seen this happen before. This is for ref# 364990 and has lot# 8179594, exp. 7/2020. Thank you for the follow up. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1917413-2019-01033 |
| MDR Report Key | 8437354 |
| Date Received | 2019-03-20 |
| Date of Report | 2019-04-09 |
| Date of Event | 2019-03-05 |
| Date Mfgr Received | 2019-03-05 |
| Device Manufacturer Date | 2018-06-28 |
| Date Added to Maude | 2019-03-20 |
| 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? PLUS PLASTIC TRANSPORT KIT FOR UA CHEMISTY URINE TESTING |
| Generic Name | SPECIMEN TRANSPORT AND STORAGE CONTAINER |
| Product Code | KDT |
| Date Received | 2019-03-20 |
| Catalog Number | 364990 |
| Lot Number | 8179594 |
| 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 | 2019-03-20 |