MAUDE Adverse Event Report: SMITHS MEDICAL PORTEX UNIPERC ADJUSTABLE FLANGE TRACHEOSTOMY TUBE

Catalog Number 100/897/090

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2015

Event Type  malfunction  

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 in use with patient for 10 days when patient pulled on the 15mm connector which resulted in it coming loose from the rest of the tube.Staff taped connector back in place to maintain ventilation.No adverse health outcome resulted from this event.

Manufacturer Narrative

One used sample was returned for evaluation with 15mm connector detached.No visible defects or non-conformities were found during visual inspection of connector and tube size.The 15mm connector was observed to be covered by residue from a tape that was used for temporary connection following the reported event.The residue was removed with an alcohol wipe before continuing with evaluation.The 15mm connector was then inserted back to the tube (using force) and an attempt made to simulated the reported issue of detachment.Investigator found it difficult to remove the 15mm connector from the tube; therefore investigation was unable to confirm the reported failure.Instructions for use warns in point 8.11," warning: during and after attachment of the breathing system to the tracheostomy tube connector, avoid application of excessive rotational or linear forces on the tube to prevent accidental disconnection or occlusion.".

• Brand Name: PORTEX UNIPERC ADJUSTABLE FLANGE TRACHEOSTOMY TUBE
• Type of Device: TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL; boundary road; hythe, kent CT216 JL; UK CT216JL
• Manufacturer (Section G): SMITHS MEDICAL; boundary road; hythe, kent CT216 JL; UK CT216JL
• Manufacturer Contact: michele seliga ; 1265 grey fox road; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5261043
• MDR Text Key: 32504874
• Report Number: 2183502-2015-00926
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K083031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/02/2015

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: Health Professional
• Device Catalogue Number: 100/897/090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/13/2015
• Initial Date FDA Received: 12/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1