BRONCHO-CATH R8602 95893

MAUDE Adverse Event Report

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.

Event Text Entries

[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

MAUDE Entry Details

• 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

Device Details

• 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

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1993-10-04