MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-07-22 for ENDOTRACHEAL TUBE SIZE 7.0 43156-070 manufactured by Baxter Healthcare Corp.
[4822]
Patient already restrained when patient extubated herself. Balloon on tube was found to be partially deflated. Patient was sedated and intubated for a seconc time and again the balloon was deflated causing the patient to extubate herself. Stress and trauma of intubation was following result. Device labeled for single use. Patient medical status prior to event: critical condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: visual examination. Results of evaluation: pilot balloon valve. Conclusion: device failure occurred and was related to event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device returned to manufacturer/dealer/distributor. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6786 |
| MDR Report Key | 6786 |
| Date Received | 1993-07-22 |
| Date of Report | 1993-02-17 |
| Date of Event | 1993-01-28 |
| Date Facility Aware | 1993-01-28 |
| Report Date | 1993-02-17 |
| Date Reported to Mfgr | 1993-02-16 |
| Date Added to Maude | 1993-10-15 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOTRACHEAL TUBE SIZE 7.0 |
| Product Code | LNZ |
| Date Received | 1993-07-22 |
| Catalog Number | 43156-070 |
| Lot Number | NA |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 6469 |
| Manufacturer | BAXTER HEALTHCARE CORP |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1993-07-22 |