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 43156-XXX manufactured by Mallinkrodt Medical.
[3587]
Patient extubated herself balloon on tube found to be deflated, patient had to be reintubated. Dept discarded tube, third occurance with this product. 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. Invalid data - regarding evaluation by user after event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: device failure occurred and was related to event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device returned to manufacturer/dealer/distributor. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6789 |
| MDR Report Key | 6789 |
| Date Received | 1993-07-22 |
| Date of Report | 1993-04-16 |
| Date of Event | 1993-03-10 |
| Date Facility Aware | 1993-03-10 |
| Report Date | 1993-04-16 |
| Date Reported to Mfgr | 1993-04-16 |
| 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 |
| Product Code | LNZ |
| Date Received | 1993-07-22 |
| Catalog Number | 43156-XXX |
| Lot Number | NA |
| Device Availability | N |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 6472 |
| Manufacturer | MALLINKRODT MEDICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1993-07-22 |