MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-21 for RUSCH SIZE 3.0 CUFFED ET TUBE. manufactured by Teleflex Medical.
[67832123]
Patient Sequence No: 1, Text Type: N, H10
[67832124]
While drawing labs from femoral broviac, which is positional, gently straightened patient's leg to draw. Patient became agitated. Patient was laying on left side but started arching back more and turning toward right side. Patient repositioned to right side while holding patient's arms down. Vent circuit tubing repositioned without issue. As finished repositioning patient, found the endotracheal tube (ett) cuff tubing next to patient in the bed. Patient's cuff was already deflated. Tubing appeared to be fully intact and had come off from the base (the patient did not bite the tubing off). Patient vs and etco2 remained stable throughout. Ordered cxr; patient ett remained at 11. 5 cm at the lip. At no point during this situation was the ett or circuit tubing pulled on. Unclear how the cuff tubing dislodged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6345320 |
| MDR Report Key | 6345320 |
| Date Received | 2017-02-21 |
| Date of Report | 2017-02-01 |
| Date of Event | 2017-01-02 |
| Report Date | 2017-02-01 |
| Date Reported to FDA | 2017-02-01 |
| Date Reported to Mfgr | 2017-02-01 |
| Date Added to Maude | 2017-02-21 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | RUSCH SIZE 3.0 CUFFED ET TUBE. |
| Generic Name | CUFF, TRACHEAL TUBE, INFLATABLE |
| Product Code | BSK |
| Date Received | 2017-02-21 |
| ID Number | SIZE 3.0 CUFFED ET TUBE |
| Operator | NURSE |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | 3015 CARRINGTON MILL BLVD. MORRISVILLE NC 27560 US 27560 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-21 |