MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-17 for 120 ML BD VACUTAINER? PLASTIC URINE COLLECTION CUP 364975 manufactured by Becton, Dickinson & Co..
[80302492]
A sample is not available for evaluation. A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6272827. Without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer? S indicated failure mode. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[80302493]
It was reported that a patient care giver suffered a needle stick injury before use from a 120 ml bd vacutainer plastic urine collection cup. There was no report of medical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1917413-2017-00021 |
| MDR Report Key | 6716888 |
| Date Received | 2017-07-17 |
| Date of Report | 2018-02-15 |
| Date of Event | 2017-06-14 |
| Date Mfgr Received | 2017-06-21 |
| Device Manufacturer Date | 2016-09-28 |
| Date Added to Maude | 2017-07-17 |
| 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 & CO. |
| 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 | 120 ML BD VACUTAINER? PLASTIC URINE COLLECTION CUP |
| Generic Name | URINE COLLECTION CUP |
| Product Code | JXA |
| Date Received | 2017-07-17 |
| Catalog Number | 364975 |
| Lot Number | 6272827 |
| Device Expiration Date | 2018-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON & CO. |
| Manufacturer Address | 150 SOUTH 1ST AVENUE BROKEN BOW NE 68822 US 68822 |
| Brand Name | 120 ML BD VACUTAINER? PLASTIC URINE COLLECTION CUP |
| Generic Name | URINE COLLECTION CUP |
| Product Code | KDT |
| Date Received | 2017-07-17 |
| Catalog Number | 364975 |
| Lot Number | 6272827 |
| Device Expiration Date | 2018-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON & CO. |
| Manufacturer Address | 150 SOUTH 1ST AVENUE BROKEN BOW NE 68822 US 68822 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-07-17 |