MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-03 for 120 ML BD VACUTAINER? PLASTIC URINE COLLECTION CUP WITH SAMPLING DEVICE 364975 manufactured by Becton, Dickinson & Co..
[59455753]
Medical device brand name: 120 ml bd vacutainer? Plastic urine collection cup with integrated sampling device. (b)(4). Device evaluation: result - no samples or photos were returned for evaluation. A review of the device history record cannot be completed as the lot number was not provided for this incident. Conclusion - although based on receipt of this complaint bd acknowledges that the customer has had an issue with this particular product, for plant evaluation purposes this is not confirmed. Bd will continue to monitor this defect for tracking and trending purposes. The bd quality engineer notes that the product label reads "caution: product contains needle under label".
Patient Sequence No: 1, Text Type: N, H10
[59455754]
It was reported that elderly patients with poor eyesight are removing the yellow sticker covering the needle on the suspect device and sticking themselves on the unused needle. This has been reported to have occurred five times.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1917413-2016-00016 |
| MDR Report Key | 6077438 |
| Date Received | 2016-11-03 |
| Date of Report | 2016-10-19 |
| Date of Event | 2016-10-14 |
| Date Mfgr Received | 2016-10-14 |
| Date Added to Maude | 2016-11-03 |
| 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 | BIOMEDICAL ENGINEER |
| 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 WITH SAMPLING DEVICE |
| Generic Name | COLLECTION CUP |
| Product Code | JXA |
| Date Received | 2016-11-03 |
| Catalog Number | 364975 |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-11-03 |