MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. HUDSON ET TUBE HOLDER, STANDARD; TRACHEAL TUBE FIXATION DEVICE

Model Number	IPN914324
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "the pads are not sticking".No patient injury or harm reported.Patient condition unknown.
Additional Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as it was reported that no sample is available for return.According to the suggested directions for use for this device in the ifu "before applying the device the patient's skin should be clean, dry and free of oily residue.The use of skin gel wipes or other skin preps with the et tube holder is not recommended.Also, the two skin barrier pads should be press onto patient's skin and hold in place until they adhere well (approximately 30 seconds)." without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "the pads are not sticking".No patient injury or harm reported.Patient condition unknown.

• Brand Name: HUDSON ET TUBE HOLDER, STANDARD
• Common Device Name: TRACHEAL TUBE FIXATION DEVICE
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 11342662
• Report Number: 8040412-2021-00034
• Device Sequence Number: 3801911
• Product Code: CBH
• UDI-Device Identifier: 14026704646965
• UDI-Public: 14026704646965
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2021

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
• Operator of Device: No Information
• Device Model Number: IPN914324
• Device Catalogue Number: 81801
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 03/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.