MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-21 for 4-WAY STOPCOCK manufactured by B. Braun Medical Inc..
[175673244]
When tightening 3-way stop cock (because 3 in a row were not aligned it looked like one may be lose) luer lock part of stop cock broke off remaining on attached stop cock.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610399 |
| MDR Report Key | 9610399 |
| Date Received | 2020-01-21 |
| Date of Report | 2020-01-10 |
| Date of Event | 2020-01-07 |
| Report Date | 2020-01-10 |
| Date Reported to FDA | 2020-01-10 |
| Date Reported to Mfgr | 2020-01-21 |
| Date Added to Maude | 2020-01-21 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | 4-WAY STOPCOCK |
| Generic Name | TUBE, TISSUE CULTURE |
| Product Code | KJG |
| Date Received | 2020-01-21 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN MEDICAL INC. |
| Manufacturer Address | 824 TWELFTH AVENUE BETHLEHEM PA 18018 US 18018 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-21 |