MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-29 for BD VACUTAINER? Z (NO ADDITIVE) PLUS URINE TUBE 364915 manufactured by Becton, Dickinson And Company (bd).
[140937507]
Medical device expiration date: unknown. Batch number [818377] was not found for material number [364915] (b)(6). Device manufacture date: unknown. Investigation summary: bd received samples and photos from the customer facility for investigation. The photos were evaluated and the customer? S indicated failure mode for collapsed tubes with the incident lot was observed. Additionally, evaluation of the customer samples was performed and collapsed tubes was observed. A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformance during manufacturing of the product. Bd has initiated further investigation relating to this issue through a capa and potential causes have been identified. As a result, corrective actions have been established and are in the process of being implemented. Investigation conclusion: based on evaluation of the customer photos, the customer? S indicated failure mode for collapsed tubes with the incident lot was observed. Additionally, evaluation of the customer samples was conducted and collapsed tubes was observed. Further investigation activities have been conducted through a capa and the most likely root cause has been identified. As a result, corrective actions and procedures are being implemented to mitigate further occurrences. Root cause description: a capa was conducted to document further investigation and root cause analysis relating to this issue. The investigation has identified the most likely root causes and corrective actions are in the process of being implemented. Rationale: based on an assessment of severity and frequency, it was determined that a capa is required at this time in order to determine the root cause associated with this issue. The investigation has identified potential root cause(s) for this issue and corrective actions are in the process of being implemented.
Patient Sequence No: 1, Text Type: N, H10
[140937508]
It was reported that before use of the bd vacutainer? Z (no additive) plus urine tube was collapsed. The tubes being collapsed was observed by end user prior to use. There were 11 occurrence. The following information was provided by the initial reporter: collapsed tubes observed by end user prior to use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617032-2019-00365 |
| MDR Report Key | 8465357 |
| Date Received | 2019-03-29 |
| Date of Report | 2019-03-20 |
| Date of Event | 2019-03-05 |
| Date Mfgr Received | 2019-03-08 |
| Date Added to Maude | 2019-03-29 |
| 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 | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD VACUTAINER? Z (NO ADDITIVE) PLUS URINE TUBE |
| Generic Name | TRANSPORT CULTURE MEDIUM |
| Product Code | JSL |
| Date Received | 2019-03-29 |
| Returned To Mfg | 2019-03-22 |
| Catalog Number | 364915 |
| Lot Number | UNKNOWN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON AND COMPANY (BD) |
| Manufacturer Address | BELLIVER WAY BELLIVER INDUSTRIAL ESTATE PLYMOUTH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-29 |