MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-28 for BD PHASEAL? INJECTOR LUER LOCK N35 515003 manufactured by Becton Dickinson, S.a..
[93848995]
Results: a sample is not available for evaluation. A review of the device history record could not be performed as a lot number was not provided for this incident. In the event that new, changed, or corrected information is obtained, a supplemental report will be filed. Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer? S indicated failure mode.
Patient Sequence No: 1, Text Type: N, H10
[93848996]
It was reported that a leakage occurred while using a bd phaseal? Injector luer lock n35. The leakage was reported to be caused from the disconnection of the phaseal connection causing chemo spillage. The nurse using the device was not exposed and the patient was cleaned. It was also reported there was an issue with the needle of the device failing to retract thus exposing the needle. There was no report of injury or medical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003152976-2017-00151 |
| MDR Report Key | 7063481 |
| Date Received | 2017-11-28 |
| Date of Report | 2017-11-20 |
| Date of Event | 2017-05-29 |
| Date Mfgr Received | 2017-10-31 |
| Date Added to Maude | 2017-11-28 |
| 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, S.A. |
| Manufacturer Street | CAMINO DE VALDEOLIVIA S/N |
| Manufacturer City | SAN AGUSTIN DE GUADALIX |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD PHASEAL? INJECTOR LUER LOCK N35 |
| Generic Name | INJECTOR |
| Product Code | ONG |
| Date Received | 2017-11-28 |
| Catalog Number | 515003 |
| Lot Number | UNKNOWN |
| Operator | NURSE |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON, S.A. |
| Manufacturer Address | CAMINO DE VALDEOLIVIA S/N SAN AGUSTIN DE GUADALIX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-28 |