MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-11 for TAPERGUARD EVAC ORAL TRACHEAL TUBE manufactured by Covidien.
[105441768]
The patient was intubated in the afternoon by anesthesia. Later in the afternoon, the staff was having difficulty ventilating the patient and the patient was able to vocalize around the tube. The patient was reintubated by the sicu attending. After the reintubation, the sicu attending examined the tube and found a defect in the balloon. Not long after the reintubation , the patient was having low expiratory volumes again and the balloon of the new ett was not holding air either. There have been several other similar balloon failures noted by staff. None identified on this patient nor the other pts where the balloon issue occurred. Staff have been instructed to save the wrapping from future events where balloons are found to be defective.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076441 |
| MDR Report Key | 7424913 |
| Date Received | 2018-04-11 |
| Date of Report | 2018-04-10 |
| Date of Event | 2018-03-07 |
| Date Added to Maude | 2018-04-12 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | TAPERGUARD EVAC ORAL TRACHEAL TUBE |
| Product Code | ETT |
| Date Received | 2018-04-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | MANSFIELD MA 02048 US 02048 |
| Brand Name | TAPERGUARD EVAC ORAL TRACHEAL TUBE |
| Product Code | ETT |
| Date Received | 2018-04-11 |
| Model Number | 7.5MM I.D. |
| Lot Number | 17J0099JZX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHILEY |
| Manufacturer Address | MANSFIELD MA 02048 US 02048 |
| Brand Name | TAPERGUARD EVAC ORAL TRACHEAL TUBE |
| Product Code | ETT |
| Date Received | 2018-04-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | SHILEY |
| Manufacturer Address | MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-04-11 |