* 9306

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-01-03 for * 9306 manufactured by Tidi Products, Llc.

Event Text Entries

[20790264] Patient was on ventilator and rn was using tidi saliva extractor during cleansing of patient's oral cavity. During the process, the rn noticed that the tip of the saliva extractor was missing from the device. The rn did an immediate search of the oral cavity and was unable to locate the tip. The attending md used a glide scope for visualization above the et tube tracheal cuff. The tip was not located. Chest x-rays were completed and the tip was not noted in either lung. Patient was extubated successfully. Tip not located, presumed tip entered stomach. Patient has recovered and has suffered no injury as a result of the tip. Icu leadership noted that the outside of the packaging (bulk pack) has a small box stating "warning! A loose tip can create a choking hazard. Check tip before use. " concern is that the rn is grabbing this non-sterile product from a large bulk pack and will not notice the warning. Attempts to remove the tip from other devices in the same pack were unsuccessful. Icu has removed this product from stock and is sourcing a single piece alternative.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2408788
• MDR Report Key: 2408788
• Date Received: 2012-01-03
• Date of Report: 2011-11-30
• Date of Event: 2011-11-29
• Report Date: 2011-11-30
• Date Reported to FDA: 2012-01-03
• Date Added to Maude: 2012-01-10
• 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: 3
• Health Professional: 3
• Initial Report to FDA: 3
• 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: *
• Generic Name: SALIVA EJECTOR
• Product Code: DYN
• Date Received: 2012-01-03
• Model Number: 9306
• Catalog Number: 9306
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: 1 DY
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: TIDI PRODUCTS, LLC
• Manufacturer Address: 570 ENTERPRISE DRIVE NEENAH WI 54956 US 54956

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-01-03