4681A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-04-27 for 4681A manufactured by Baxter.

Event Text Entries

[3051] Our patient was receiving am trach care by our nurse. While cleaning exudate around inner cannula q tip (sterile) broke off and approx. 1/2" tip and plastic stick was inhaled into inner cannula. Patient became biaphoretic immediately with increased respirations of 32/min. Patient was experiencing blood tinged secretion from trach. Color of patient was rubba red. Nurse suctioned to remove excess secretions, paramedics called. Patient had some relief post suction. Patient removed to hospital where surgery was necessarydevice labeled for single use. Patient medical status prior to event: fair 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: a device from same lot was evaluated, visual examination, other. Results of evaluation: component failure, design - inadequate. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device use continued with restrictions/limitations, other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 5166
• MDR Report Key: 5166
• Date Received: 1993-04-27
• Date of Report: 1993-03-24
• Date of Event: 1993-03-14
• Date Facility Aware: 1993-03-14
• Report Date: 1993-03-24
• Date Reported to Mfgr: 1993-03-23
• Date Added to Maude: 1993-06-29
• 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

• Generic Name: TRACHEOSTOMY CLEANING TRAY/WITH GLOVES
• Product Code: LRQ
• Date Received: 1993-04-27
• Catalog Number: 4681A
• Lot Number: Y2P305
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-MAR-93
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 4868
• Manufacturer: BAXTER

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1993-04-27