MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-14 for KIT URIN CUP 16X100 8.0 CONI UAP RD/YEL 364946 manufactured by Becton, Dickinson & Co. (broken Bow).
[145154313]
(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
[145154314]
It was reported that underfill occurred with kit urine cup 16 x 100 8. 0 coni uap rd/yel. The following information was provided by the initial reporter, "the tubes with the urine kit's conservator drains below the minimum line. Information received by email on 05/03/2019: it was reported at least 10 tubes without vacuum. They did not had any lot number changes (all affected products is from the same lot number). The tubes is stocked in ambient temperature (about 8? C and 22? C). The customer follow the fabricator instructions to perform the draining. '' 4200 occurrences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1917413-2019-01462 |
| MDR Report Key | 8608105 |
| Date Received | 2019-05-14 |
| Date of Report | 2019-06-19 |
| Date of Event | 2019-04-16 |
| Date Mfgr Received | 2019-04-23 |
| Device Manufacturer Date | 2018-02-28 |
| Date Added to Maude | 2019-05-14 |
| 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 | KIT URIN CUP 16X100 8.0 CONI UAP RD/YEL |
| Generic Name | URINE COLLECTION DEVICE |
| Product Code | KDT |
| Date Received | 2019-05-14 |
| Catalog Number | 364946 |
| Lot Number | 8059545 |
| Device Expiration Date | 2019-09-30 |
| Device Availability | * |
| 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 | 2019-05-14 |