MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-26 for BD VACUTAINER? URINE COLLECTION CUP 364975 manufactured by Becton, Dickinson & Co. (broken Bow).
[139959276]
Date of event: unknown. Medical 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
[139959277]
It was reported that the lid on the bd vacutainer? Urine collection cup was not leak-proof when properly secured, causing urine leakage that soiled that exterior of the cup and biohazard transport bag. Some samples were reportedly "refused" due to the excessive leakage, requiring patients to be recalled by the physician to recollect and delaying treatment. The following information was provided by the initial reporter: "the lids are not leak-proof even when properly sealed and screwed. The exterior of the cup is soiled and there is urine in the biohazard transport bag. Some samples are refused due to excessive leakage. The patients need to be recalled by the physician to repeat the sample. Test results and therefore treatment are delayed. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1917413-2019-01048 |
| MDR Report Key | 8453041 |
| Date Received | 2019-03-26 |
| Date of Report | 2019-04-04 |
| Date of Event | 2019-03-11 |
| Date Mfgr Received | 2019-03-11 |
| Date Added to Maude | 2019-03-26 |
| 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 COLLECTION CUP |
| Generic Name | SPECIMEN TRANSPORT AND STORAGE CONTAINER |
| Product Code | KDT |
| Date Received | 2019-03-26 |
| Catalog Number | 364975 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| 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 |
|---|---|---|---|
| 0 | 0 | 1. Required No Informationntervention | 2019-03-26 |