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	Insufficient Information (4580)
Date of Event	12/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Complaint from maude database: we had two intubated patients whose endotracheal tubes were secured using the device.Both patients were prone.When the therapist turned the first patient's head, the device broke.In the case of the second patient, the holders slid off the track.Respiratory therapy reported incidentally there were multiple instances over the weekend of the tube holders breaking while in use.Manufacturer response for endotracheal tube holder, gentle-lock (per site reporter).We are returning the remaining stock we have to the manufacturer.While we are not certain of the lot numbers of the holders involved, one of the boxes we have contains lot #35063.
Event or Problem Description
Complaint from maude database: we had two intubated patients whose endotracheal tubes were secured using the device.Both patients were prone.When the therapist turned the first patient's head, the device broke.In the case of the second patient, the holders slid off the track.Respiratory therapy reported incidentally there were multiple instances over the weekend of the tube holders breaking while in use.Manufacturer response for endotracheal tube holder, gentle-lock (per site reporter).We are returning the remaining stock we have to the manufacturer.While we are not certain of the lot numbers of the holders involved, one of the boxes we have contains lot #35063.
Additional Manufacturer Narrative
Qn#(b)(4).Mdr report key/report number: (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.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.

• 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: 11348070
• Report Number: 8040412-2021-00032
• Device Sequence Number: 11789006
• Product Code: CBH
• UDI-Device Identifier: 14026704646965
• UDI-Public: 14026704646965
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2021

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: 35063
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/29/2021
• Supplement Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 02/19/2021
• 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: NONE REPORTED; NONE REPORTED; NONE REPORTED.