MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-15 for STRYKEFLOW 2 DISPOSABLE SUCTION/IRRIGATOR 250-070-520 manufactured by Stryker/stryker Endoscopy.
[124147558]
After suction irrigator used, fluid from normal saline bag was leaking and dripping on the floor. The fluid had black specs in it. Irrigator was put into packaging and sent to risk management.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080568 |
| MDR Report Key | 7969000 |
| Date Received | 2018-10-15 |
| Date of Report | 2018-10-11 |
| Date of Event | 2018-10-08 |
| Date Added to Maude | 2018-10-16 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Brand Name | STRYKEFLOW 2 DISPOSABLE SUCTION/IRRIGATOR |
| Generic Name | SYSTEM, IRRIGATION, UROLOGICAL |
| Product Code | LJH |
| Date Received | 2018-10-15 |
| Catalog Number | 250-070-520 |
| Lot Number | 18094FG2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER/STRYKER ENDOSCOPY |
| Manufacturer Address | 5900 OPTICAL CT. SAN JOSE CA 95138 US 95138 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-15 |