MAUDE Adverse Event Report: CROSSTEX INTERNATIONAL, INC. PREMIUM; SALIVA EJECTOR SUCTION CATHETER

Catalog Number ZCB

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2014

Event Type  malfunction  

Event Description

During an esophagogastroduodenoscopy (egd) the clinician was suctioning the patient's mouth and discovered the tip of the oral suction catheter had come off into the mouth of the patient.The physician was able to retrieve the plastic tip without incident or harm to the patient.

• Brand Name: PREMIUM
• Type of Device: SALIVA EJECTOR SUCTION CATHETER
• Manufacturer (Section D): CROSSTEX INTERNATIONAL, INC.; 10 ranick rd; hauppauge NY 11788
• MDR Report Key: 4371917
• MDR Text Key: 5290097
• Report Number: 4371917
• Device Sequence Number: 1
• Product Code: DYN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: ZCB
• Device Lot Number: 07/08/14 3
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/18/2014
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/30/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 66