MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-30 for IV PLUS? BD6010 manufactured by Nexus Medical, Llc.
[134460975]
Device leaked blood at the luer lock connector. Manufacturer response for blood collection assembly with male luer lock, nexus (per site reporter). Will pick up.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8288283 |
| MDR Report Key | 8288283 |
| Date Received | 2019-01-30 |
| Date of Report | 2019-01-15 |
| Date of Event | 2018-12-10 |
| Report Date | 2019-01-15 |
| Date Reported to FDA | 2019-01-15 |
| Date Reported to Mfgr | 2019-01-30 |
| Date Added to Maude | 2019-01-30 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IV PLUS? |
| Generic Name | SYSTEM, BLOOD COLLECTION, VACUUM-ASSISTED, MANUAL |
| Product Code | KST |
| Date Received | 2019-01-30 |
| Model Number | BD6010 |
| Lot Number | 18192 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEXUS MEDICAL, LLC |
| Manufacturer Address | 11315 STRANG LINE ROAD LENEXA KS 66215 US 66215 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-30 |