MAUDE Adverse Event Report: CROSS PROTECTION M SDN BHD CROSS PROTECTION; SALIVA EJECTOR

Model Number 5-501 CB

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

The tip of ejector fell of clear tube post endotracheal intubation into oropharynx.The device was intact prior use and was performed properly during first three oral suctions.

• Brand Name: CROSS PROTECTION
• Type of Device: SALIVA EJECTOR
• Manufacturer (Section D): CROSS PROTECTION M SDN BHD; no. 11, jalan perindustrian 5, batu 5 1/2; off jalan haji abdul manan; klang se langor 41050 ; MY 41050
• MDR Report Key: 6996097
• MDR Text Key: 90973748
• Report Number: MW5073095
• Device Sequence Number: 1
• Product Code: DYN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2021
• Device Model Number: 5-501 CB
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 4 YR
• Patient Weight: 17