MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-22 for BD VACUTAINER? SODIUM FLUORIDE 3.0MG N2E 6.0 MG PLUS BLOOD COLLECTION TUBES 367929 manufactured by Becton, Dickinson & Co..
[108985297]
Medical device expiration date: unknown. Device manufacture date: unknown. Bd received samples and photos from the customer facility for investigation. The samples and photos were evaluated and the customer? S indicated failure mode with the incident lot was observed. Additionally, a review of the manufacturing records was completed for the incident lot and no issues were identified.
Patient Sequence No: 1, Text Type: N, H10
[108985298]
It was reported that the bd vacutainer? Sodium fluoride 3. 0mg n2e 6. 0mg plus blood collection tubes had stopper creep out or loose closure caused no serious injury medical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1917413-2018-02441 |
| MDR Report Key | 7532065 |
| Date Received | 2018-05-22 |
| Date of Report | 2018-05-02 |
| Date of Event | 2017-10-05 |
| Date Mfgr Received | 2017-10-05 |
| Date Added to Maude | 2018-05-22 |
| 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? SODIUM FLUORIDE 3.0MG N2E 6.0 MG PLUS BLOOD COLLECTION TUBES |
| Generic Name | BLOOD SPECIMEN COLLECTION DEVICE |
| Product Code | OFZ |
| Date Received | 2018-05-22 |
| Returned To Mfg | 2017-10-26 |
| Catalog Number | 367929 |
| Lot Number | 7016715 |
| 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 | 2018-05-22 |