MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-03 for BD VACUTAINER? ECLIPSE? SIGNAL? BLOOD COLLECTION NEEDLE 368838 manufactured by Becton, Dickinson And Company (bd).
[107504548]
Investigation results: summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited. Retention samples were selected from bd inventory for testing and upon completion, no issues were observed relating to sleeve leakage as all samples met specifications. 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. Conclusion: based on evaluation of the retain samples, the customer? S indicated failure mode for sleeve leakage with the incident lot was not observed as all samples met the required specifications. Root cause: based on the investigation, a root cause could not be determined. The retain product was found to be in conformance and meet release specifications.
Patient Sequence No: 1, Text Type: N, H10
[107504549]
It was reported there was leakage found on a vacutainer? Eclipse? Signal? Blood collection needle when removing the needle from the tube. There was no report of exposure, serious injury or medical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617032-2018-00112 |
| MDR Report Key | 7484926 |
| Date Received | 2018-05-03 |
| Date of Report | 2018-04-12 |
| Date of Event | 2018-04-10 |
| Date Mfgr Received | 2018-04-11 |
| Device Manufacturer Date | 2017-11-24 |
| Date Added to Maude | 2018-05-03 |
| 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 | PHARMACIST |
| 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 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? ECLIPSE? SIGNAL? BLOOD COLLECTION NEEDLE |
| Generic Name | BLOOD COLLECTION SET |
| Product Code | PJE |
| Date Received | 2018-05-03 |
| Catalog Number | 368838 |
| Lot Number | 7328827 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-05-03 |