MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX® UNIPERC® ADJUSTABLE FLANGE EXTENDED-LENGTH TRACHEOSTOMY TUBES ADD TO IN

Catalog Number 100/897/070

Device Problems Disconnection (1171); Connection Problem (2900)

Patient Problems Extubate (2402); Patient Problem/Medical Problem (2688)

Event Date 02/23/2016

Event Type  Injury  

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

User facility reported that the device was placed in use with patient.According to reporter, the ventilator tubing became detached from the tube during use.In original user report, the user facility reported the issue led to inability to ventilate and described potential patient harm.Upon request for additional information, the user facility later reported to smiths medical that the device issue led to patient having to be re-intubated with "deterioration in condition for period afterwards".Additional information will be requested.No permanent adverse effects reported at this time.

Manufacturer Narrative

The reported uniperc adjustable flange tracheostomy tube cuffed, 7mm device was returned for investigation.Under visual inspection the failure was confirmed - 15mm white connector was disconnected from the tube.There were no other defects or damages observed.Therefore complaint is confirmed as a manufacturing issue.Mfr# clarification: (b)(4).

• Brand Name: PORTEX® UNIPERC® ADJUSTABLE FLANGE EXTENDED-LENGTH TRACHEOSTOMY TUBES ADD TO IN
• Type of Device: TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, CT21 6JL; UK CT21 6JL
• Manufacturer Contact: michele seliga ; 1265 grey fox rd.; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5520361
• MDR Text Key: 41007943
• Report Number: 2183502-2016-00583
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K083031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 100/897/070
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2016
• Initial Date FDA Received: 03/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/06/2016
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention