MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-10-04 for BRONCHO-CATH R8602 95893 manufactured by Mallinckrodt Critical Care.
[3542]
Patient had left thoracotomy and left pneumonectomy. At end of case anesthesia was unable to extubate patient. Fiberoptic bronchoscopy performed and incision re-0pened. Endobronchial tube inadvertently sutured. Suture cut and endobronchial tube removed. Patient discharged 12/28/91 without complications. Device labeled for single use. Patient medical status prior to event: satisfactory 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: actual device involved in incident was evaluated, visual examination. Results of evaluation: none or unknown, other, invalid data. Conclusion: no failure detected and product within specification, user error contributed to event. Certainty of device as cause of or contributor to event: yes. Corrective actions: other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6719 |
| MDR Report Key | 6719 |
| Date Received | 1993-10-04 |
| Date of Report | 1992-02-19 |
| Date of Event | 1991-12-19 |
| Date Facility Aware | 1991-12-19 |
| Report Date | 1992-02-19 |
| Date Reported to Mfgr | 1992-02-10 |
| Date Added to Maude | 1993-10-13 |
| 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 | BRONCHO-CATH |
| Generic Name | ENDOBRONCHIAL TUBE |
| Product Code | KTR |
| Date Received | 1993-10-04 |
| Model Number | R8602 |
| Catalog Number | 95893 |
| Lot Number | ML01680 |
| ID Number | 37 FR. STYLE: LEFT |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 6403 |
| Manufacturer | MALLINCKRODT CRITICAL CARE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1993-10-04 |