MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-11 for BD VACUTAINER? BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE 364955 manufactured by Becton, Dickinson & Co..
[111020641]
Pma / 510(k) #: there is no 510(k) given for this device. Investigation summary: bd received samples from the customer facility for investigation. The samples were tested/evaluated and the customer's indicated failure mode for closure separation with the incident lot was not observed as all product specifications were met. 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-conformances during manufacturing of the product. Investigation conclusion: based on evaluation of the customer samples, the customer? S indicated failure mode for closure separation with the incident lot was not observed as all samples met the required specifications. Root cause description: based on the investigation, a root cause could not be determined. The product was found to be in conformance and meet release specifications. Rationale: complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored. The bd business team regularly reviews the collected data for identification of emerging trends.
Patient Sequence No: 1, Text Type: N, H10
[111020642]
It was reported that bd vacutainer? Boric acid sodium borate/formate c&s urine tube the stopper being stuck in the tube. No report of injury or medical intervention. No report of blood exposure to mucous membrane.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1917413-2018-01621 |
| MDR Report Key | 7587034 |
| Date Received | 2018-06-11 |
| Date of Report | 2018-05-17 |
| Date of Event | 2018-03-13 |
| Date Mfgr Received | 2018-03-13 |
| Device Manufacturer Date | 2017-05-09 |
| Date Added to Maude | 2018-06-11 |
| 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 | 0 |
| Brand Name | BD VACUTAINER? BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE |
| Generic Name | TRANSPORT CULTURE MEDIUM |
| Product Code | JSL |
| Date Received | 2018-06-11 |
| Returned To Mfg | 2018-03-22 |
| Catalog Number | 364955 |
| Lot Number | 7129942 |
| Device Expiration Date | 2018-11-03 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| 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 | 2018-06-11 |