MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2020-03-09 for BD VACUTAINER? Z (NO ADDITIVE) PLUS URINE TUBE 364915 manufactured by Becton, Dickinson And Company (bd).
[187039127]
A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[187039128]
It was reported that 116 bd vacutainer? Z (no additive) plus urine tubes did not meet the protocol requirement of "10. 38ml" during draw volume testing at "t=3 (tested at 10 months shelf time)" and underfilled. The tubes were sterilized at nominal and maximum dose levels. The following information was provided by the initial reporter: failure in draw volume test on bd vacutainer? Urine tube, catalog # 364915. As part of capa 54720, we sourced bd vacutainer? Urine plastic tube, 16x100mm, 11. 0ml (364915) which were sterilized at nominal and maximum dose levels for draw volume testing. The testing indicates both nominal and maximum dosed bd vacutainer? Urine plastic tube, 16x100mm, 11. 0ml (364915) did not meet the protocol requirement of 10. 38ml draw volume at t=3 (tested at 10 months shelf time). The urine plus tubes were designed to meet the 80mm depth of urine/column height after draw in order to completely cover the indicator pads in the dipsticks used in the urine analyser. The column height requirement will be verified by measuring the draw volume. The draw volume of 10. 38 ml will confirm the column height requirement of 80mm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617032-2020-00222 |
| MDR Report Key | 9806903 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2020-03-09 |
| Date of Report | 2020-02-19 |
| Date of Event | 2020-02-18 |
| Date Mfgr Received | 2020-02-18 |
| Device Manufacturer Date | 2019-04-15 |
| Date Added to Maude | 2020-03-09 |
| 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 AND COMPANY (BD) |
| Manufacturer Street | BELLIVER WAY BELLIVER INDUSTRIAL ESTATE |
| Manufacturer City | PLYMOUTH |
| Manufacturer Country | UK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD VACUTAINER? Z (NO ADDITIVE) PLUS URINE TUBE |
| Generic Name | TRANSPORT CULTURE MEDIUM |
| Product Code | JSM |
| Date Received | 2020-03-09 |
| Returned To Mfg | 2020-02-26 |
| Catalog Number | 364915 |
| Lot Number | 9105862 |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON AND COMPANY (BD) |
| Manufacturer Address | BELLIVER WAY BELLIVER INDUSTRIAL ESTATE PLYMOUTH UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-09 |