MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2017-01-12 for 16MM X 100MM X 8ML BD VACUTAINER? PLUS PLASTIC COLLECTION KIT 364946 manufactured by Becton, Dickinson & Co..
[64668476]
Medical device brand name: 16 mm x 100 mm x 8 ml bd vacutainer? Plus plastic collection kit for ua chemistry urine testing. With evacuated conical bottom tube, urinalysis preservative and cup. Sterile. (b)(4). Device evaluation: result - one used sample was returned for evaluation. The cup was inspected for defects with no visible defects identified. The cup was then filled with water, and closed, shaken vigorously in an attempt to produce leaks, with no leaking occurring. A review of the device history record cannot be completed as the lot number was not provided for this incident. Conclusion - the complaint for urine leakage was not confirmed. Without a sample, an absolute root cause for this incident cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
[64668477]
It was reported that the clinician was accessing the bd closed urine collection cup from the suspect device and urine splashed into his/her eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1917413-2017-00001 |
| MDR Report Key | 6246995 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2017-01-12 |
| Date of Report | 2017-01-05 |
| Date of Event | 2016-12-20 |
| Date Mfgr Received | 2016-12-20 |
| Date Added to Maude | 2017-01-12 |
| 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 | 3 |
| Brand Name | 16MM X 100MM X 8ML BD VACUTAINER? PLUS PLASTIC COLLECTION KIT |
| Generic Name | COLLECTION KIT |
| Product Code | JXA |
| Date Received | 2017-01-12 |
| Returned To Mfg | 2017-01-04 |
| Catalog Number | 364946 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-01-12 |