MAUDE Adverse Event Report: UNOMEDICAL SDN BHD TRACHEOSTOMY TUBE 8.0MM; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number MM62525080

Device Problem Air Leak (1008)

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

Event Date 11/12/2015

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.There were no reports of the patient being harmed as a result of this malfunction.Additional patient/event details have been requested.However, no further information was available at the time of the report.Should additional information become available, a follow-up report will be submitted.Expiration date: 05/2020.Device manufacture date: 05/2015.(b)(4).

Event Description

It was reported the tracheal tube cuff function was normal during pre-testing.Once the tube was inserted and the cuff was inflated, air bubbles were seen coming from the cuff within the first minute of use.As the staff was concerned about potential leakage, the tracheal tube was removed and replaced.It was noted the respirator did not alarm despite the appearance of the bubbles.No patient complications were reported.

Manufacturer Narrative

Additional information: based on the lot number provided by the customer, the assembly work order was retrieved to assist in the investigation.The assembly record does reveal 3.2% of leak at pilot balloon assembly was detected during leak test and the defective product was rejected and discarded.No other discrepancies were noted during the batch review.Complaint sample not expected and based on record review all relevant test performed during manufacturing process and final product release met specifications.No other conclusion could be drawn without performing the testing on the product and with the information available, we are unable to determine the root cause of the complaint.No further actions are required and the complaint will be closed.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.

• Brand Name: TRACHEOSTOMY TUBE 8.0MM
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): UNOMEDICAL SDN BHD; bakar arang industrial estate; sungai petani, kedah 08000 ; MY 08000
• Manufacturer (Section G): CONVATEC, INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5260773
• MDR Text Key: 32494283
• Report Number: 9611710-2015-00186
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K945874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MM62525080
• Device Lot Number: 550183R001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/13/2015
• Initial Date FDA Received: 12/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1