MAUDE Adverse Event Report: UNOMEDICAL SDN BHD TT BASIC HVLP 7.0MM; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number MM62525070

Device Problems Air Leak (1008); Inflation Problem (1310)

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

Event Date 08/23/2011

Event Type  malfunction  

Manufacturer Narrative

Convatec is submitting this report as a result of activities related to convatec remediation protocol (b)(4).Convatec is submitting this report pursuant to the provisions of 21 cfr part 803.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).

Event Description

Complainant reports "failure of cuff inflation before use.".

• Brand Name: TT BASIC HVLP 7.0MM
• 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 Contact: jeanette johnson ; 211 american ave; greensboro, NC 27409 ; 3362973009
• MDR Report Key: 5168510
• MDR Text Key: 28940006
• Report Number: 9611710-2015-30727
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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
• Report Date: 02/27/2014

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: No Information
• Device Expiration Date: 05/01/2016
• Device Model Number: MM62525070
• Device Lot Number: 540173R001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2011
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/27/2014
• Initial Date FDA Received: 10/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1