MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-14 for INLINE SUCTION CATHETER REF 210 manufactured by Halyard Health Inc..
[179435966]
Patient intubated with inline suction catheter in place. Patient vent popping off easily with cares/interventions. Noted inline to have crack in plastic that connects vent to patient's ett. Able to quickly change inline suction to fix issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9711007 |
| MDR Report Key | 9711007 |
| Date Received | 2020-02-14 |
| Date of Report | 2020-01-28 |
| Date of Event | 2020-01-18 |
| Report Date | 2020-01-28 |
| Date Reported to FDA | 2020-01-28 |
| Date Reported to Mfgr | 2020-02-14 |
| Date Added to Maude | 2020-02-14 |
| 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 | 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 | 3 |
| Brand Name | INLINE SUCTION CATHETER |
| Generic Name | CATHETERS, SUCTION, TRACHEOBRONCHIAL |
| Product Code | BSY |
| Date Received | 2020-02-14 |
| Catalog Number | REF 210 |
| Lot Number | M1828T507 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HALYARD HEALTH INC. |
| Manufacturer Address | 5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-14 |