LO-PRO, CUFFED, MURPHY EYE TRACHEAL TUBE 9.0MM I.D. 7.5MM I.D. 86055 (9.0MM) 86052 (7.5MM)

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-11-17 for LO-PRO, CUFFED, MURPHY EYE TRACHEAL TUBE 9.0MM I.D. 7.5MM I.D. 86055 (9.0MM) 86052 (7.5MM) manufactured by Mallinckrodt Medical, Inc..

Event Text Entries

[1079] On 10/26/92, a patient was brought to the emergency department in full cardiac and respiratory arrest, unresponsive and with pupils fixed and dilated. The patient was intubated by an emergency room physician with mallinckrodt #7. 5 tube. After attempting to inflate the cuff, a noticable amount of air was observed escaping around the tube. The patient was reintubated by the respiratory therapist with a #9. 0 tube. Similar observations were noted with this tube also, but it was decided by the attending physician that the tube could be used. The attempt to resuscitate the patient was unsuccessful. Evaluation of the tubes, post-code seem to show a leak from the inflatable cuff on the #7. 5 tube and a leak from the pilot valve on the #9. 0 tubedevice 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. Invalid data - regarding whether event presents imminent hazard. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, performance tests performed, visual examination. Results of evaluation: component failure, luer valve. Conclusion: device failure occurred and was related 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: 1819
• MDR Report Key: 1819
• Date Received: 1992-11-17
• Date of Report: 1992-11-05
• Date of Event: 1992-10-26
• Date Facility Aware: 1992-10-26
• Report Date: 1992-11-05
• Date Reported to FDA: 1992-11-05
• Date Reported to Mfgr: 1992-10-26
• Date Added to Maude: 1992-12-04
• 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: LO-PRO, CUFFED, MURPHY EYE TRACHEAL TUBE
• Generic Name: ENDOTRACHEAL TUBE
• Product Code: LNZ
• Date Received: 1992-11-17
• Model Number: 9.0MM I.D. 7.5MM I.D.
• Catalog Number: 86055 (9.0MM) 86052 (7.5MM)
• Lot Number: UNKNOWN
• ID Number: P/N 43157-090 (9.0MM)
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 1697
• Manufacturer: MALLINCKRODT MEDICAL, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-11-17