MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-18 for 120 ML BD VACUTAINER? PLASTIC URINE COLLECTION CUP 364975 manufactured by Becton, Dickinson & Co..
[86562522]
Investigation: a sample is not available for evaluation. A review of the device history record could not be performed as a lot number was not provided for this incident. In the event that new, changed, or corrected information is obtained, a supplemental report will be filed. Without a sample, an absolute root cause for this incident cannot be determined. Udi#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[86562523]
It was reported that one of the nurses in the er stuck her finger on the non-patient needle under the yellow sticker of the 120 ml bd vacutainer? Plastic urine collection cup. There was urine in the cup, but the needle had not been used yet to draw up sample into the tubes. The nurse is taking anti-viral medications prescribed by the infectious disease doctor at the hospital. She is 20 weeks pregnant, and has not yet contacted her obstetrician.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1917413-2017-00121 |
| MDR Report Key | 6874457 |
| Date Received | 2017-09-18 |
| Date of Report | 2017-09-05 |
| Date of Event | 2017-08-29 |
| Date Mfgr Received | 2017-08-29 |
| Date Added to Maude | 2017-09-18 |
| 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 SYSTEM |
| Product Code | JXA |
| Date Received | 2017-09-18 |
| Catalog Number | 364975 |
| Lot Number | UNKNOWN |
| Operator | NURSE |
| 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 SYSTEM |
| Product Code | KDT |
| Date Received | 2017-09-18 |
| Catalog Number | 364975 |
| Lot Number | UNKNOWN |
| Operator | NURSE |
| Device Availability | N |
| 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. Required No Informationntervention | 2017-09-18 |