MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-09-19 for STERILE IRRIGATION TRAY DYND20302 manufactured by Medline Industries, Inc..
[17415324]
The syringe tip of the 60 ml piston syringe on the tray is too small for irrigating. It does not give a good seal especially in three-way foley irrigations.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1003426 |
| MDR Report Key | 16237 |
| Date Received | 1994-09-19 |
| Date of Report | 1994-09-16 |
| Date Added to Maude | 1994-09-20 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERILE IRRIGATION TRAY |
| Product Code | EYN |
| Date Received | 1994-09-19 |
| Catalog Number | DYND20302 |
| Lot Number | 4F1013 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 16170 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | MUNDELEIN IL 600604486 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-09-19 |