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

Catalog Number ZCB

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

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

Event Date 11/10/2014

Event Type  malfunction  

Event Description

The patient was in the procedure room for percutaneous endoscopic gastrostomy (peg) placement.The clinician was suctioning the patient using a saliva ejector that was connected to suction tubing.The clinician reported that the blue tip from saliva ejector came off and was in the patient's mouth.The physician was able to keep the tip in view with the endoscope until anesthesia arrived to secure airway, and intubate if needed.Code was called.One of the code/anesthesia team clinicians was able to retrieve the tip from the patient.The patient remained stable throughout incident and was transferred to the intensive care unit (icu) after the peg procedure was completed.The saliva ejector used for the procedure was sequestered.The device was retained and similar lots were removed from the stock location.

• 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: 4371907
• MDR Text Key: 5265976
• Report Number: 4371907
• 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: 11/11/2014

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: Health Professional
• Device Catalogue Number: ZCB
• Device Lot Number: 09/0/14 1
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/18/2014
• Device Age: 3 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: 61 YR