MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-15 for NAMIC STOPCOCK 400 PSI THREEWAY STOPCOCK W / FIXED MALE LUER LOCK H965700350030 manufactured by Navilyst Medical / Angiodynamics, Inc..
[175728919]
Physician did a power injection with 400psi stopcock and it immediately malfunctioned with next hand injection. Stopcock began leaking and was removed and a new three way stopcock with 1050 psi was used without issue. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092303 |
| MDR Report Key | 9596307 |
| Date Received | 2020-01-15 |
| Date of Report | 2020-01-14 |
| Date of Event | 2020-01-10 |
| Date Added to Maude | 2020-01-16 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | NAMIC STOPCOCK 400 PSI THREEWAY STOPCOCK W / FIXED MALE LUER LOCK |
| Generic Name | ADAPTOR, STOPCOCK, MANIFIED FITTING CARDIO PULMONARY BYPASS |
| Product Code | DTL |
| Date Received | 2020-01-15 |
| Model Number | H965700350030 |
| Lot Number | 5533373 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NAVILYST MEDICAL / ANGIODYNAMICS, INC. |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-15 |