MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC, A.S. PORTEX UNIPERC ADJUSTABLE FLANGE TRACHEOSTOMY TUBE

Catalog Number 100/897/070CZ

Device Problems Bent (1059); Occlusion Within Device (1423)

Patient Problems Pulmonary Emphysema (1832); Pneumothorax (2012); Respiratory Distress (2045)

Event Type  Injury  

Manufacturer Narrative

Product sample has been made available for evaluation.The device evaluation results will be provided in a follow up report once available,.

Event Description

Distributor reported on behalf of user facility that the device was in use with patient who was located in an intensive care unit for burn patients (time in use not provided).The reporter stated the patient was manually ventilated through the tube.The reporter stated the patient showed decrease in oxygen saturation levels and in response the patient was suctioned.The treating physician administered additional oxynorm, fentanyl and propofol to patient; after this the patient ventilation became easier with oxygen saturation measured at 94%.According to reporter, the patient saturation decreased again and treating staff suspected patient had developed emphysema: in response the patient was examined via bronchoscopy.The examination showed the tracheostomy tube was obstructed and the scope could not be passed through it.The tube was removed and patient was re-intubated: reporter stated that the replacement tube could not be advanced past the vocal cords due to resistance.According to reporter, examination after the re-intubation showed subcutaneous emphysema and pneumothorax on both sides.Reporter did not confirm whether emphysema and pneumothorax was present prior to intubation.

Manufacturer Narrative

One used 7.0mm portex® uniperc® cuffed tracheostomy tube was returned for investigation; the inner cannula of the device was not returned.The device was received inside a plastic bag.The visual inspection of the returned sample showed no abnormalities.The returned device was found to be in good condition.The manufacturing facility reviewed the product documentation and verified no material changes had occurred.Manufacturing could not verify that the product did not meet with specifications.Investigation determined that no fault was present with the returned device.(b)(4).

• Brand Name: PORTEX UNIPERC ADJUSTABLE FLANGE TRACHEOSTOMY TUBE
• Type of Device: TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL CZECH REPUBLIC, A.S.; olomoucká 306; hranice 1, 75301 ; EZ 75301
• Manufacturer (Section G): SMITHS MEDICAL CZECH REPUBLIC, A.S.; olomoucká 306; hranice 1, 75301 ; EZ 75301
• Manufacturer Contact: michele seliga ; 1265 grey fox rd.; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5678480
• MDR Text Key: 45877336
• Report Number: 2183502-2016-01088
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 35019315107195
• UDI-Public: 35019315107195
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K083031
• 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: 05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 100/897/070CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/09/2016
• 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): Required Intervention