SUCTION TUBE ATTACHMENT DEVICE 9785

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-01-31 for SUCTION TUBE ATTACHMENT DEVICE 9785 manufactured by Hollister, Inc..

Event Text Entries

[101] Patient was receiving the feeding tube through ross laboratories flexiflo enternal feeding tube, no. 12 french tube. Patient was found with tube almost completely out of nose. Tube feeding was infusing into naso and oro-pharynx. Pt. Respirations were 44/min; labored and gurgling. Pt. Possibly aspirated. Feeding tube was being held in place by a hollister suction tube attachment device. Clamp was loose on device. Patient had been apneic for short periods throughout the day and was not expected to survice the night. Patient expired shortly after the above eventdevice 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. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: design, telemetry failure, none or unknown. Conclusion: no data. Certainty of device as cause of or contributor to event: maybe. Corrective actions: use of all similar devices stopped temporarily. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 169
• MDR Report Key: 169
• Date Received: 1992-01-31
• Date of Report: 1992-01-14
• Date of Event: 1991-12-27
• Date Facility Aware: 1991-12-27
• Report Date: 1992-01-14
• Date Reported to FDA: 1992-01-14
• Date Reported to Mfgr: 1992-01-14
• Date Added to Maude: 1992-04-02
• 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: SUCTION TUBE ATTACHMENT DEVICE
• Generic Name: TUBE FEEDING HOLDING DEVICE
• Product Code: EWT
• Date Received: 1992-01-31
• Model Number: 9785
• Catalog Number: 9785
• Lot Number: UNKNOWN
• ID Number: N/A
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-NOV-91
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 166
• Manufacturer: HOLLISTER, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1992-01-31