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 2020-02-10 for BD VACUTAINER? Z (NO ADDITIVE) PLUS URINE TUBE 364915 manufactured by Becton, Dickinson And Company (bd).
[187076988]
(b)(6). 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
[187076989]
It was reported that a cracked tube occurred before use with a bd vacutainer? Z (no additive) plus urine tube. The following information was provided by the initial reporter, "it was reported during bd internal testing that the tubes failed drop test under ratings 3 and 4 which are considered to have exposure to blood borne pathogens. Bd vacutainer? Urine tubes catalog # 364915. As part of capa (b)(4), we found that above mentioned catalogs had failures of drop test under ratings 3 & 4 which are considered to have exposure to blood borne pathogens. Each catalog had 300 nominal dosed samples and 300 maximum dosed samples for drop testing. All the samples are tested. There is no root cause found for these failures. Irradiation dose (kgy): maximum (35. 6-42. 6)" 5 occurrences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617032-2020-00104 |
| MDR Report Key | 9689130 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2020-02-10 |
| Date of Report | 2020-02-19 |
| Date of Event | 2019-05-29 |
| Date Mfgr Received | 2020-01-20 |
| Device Manufacturer Date | 2019-04-15 |
| Date Added to Maude | 2020-02-10 |
| 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 | 2020-02-10 |
| Returned To Mfg | 2020-01-22 |
| Catalog Number | 364915 |
| Lot Number | 9105862 |
| Device Availability | R |
| Device Age | DA |
| 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 | 2020-02-10 |