MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. PORTEX® UNIPERC® ADJUSTABLE FLANGE TRACHEOSTOMY TUBES; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 100/897/080

Device Problems Human-Device Interface Problem (2949); Infusion or Flow Problem (2964)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 08/26/2018

Event Type  Injury  

Event Description

It was reported that a cadd® cadd® extension set was leaking at the filter.No patient injury.

Manufacturer Narrative

Report source: (b)(6).

Event Description

Information was received indicating that 48 hours following placement of a smiths medical portex® uniperc® adjustable flange extended-length tracheostomy tube, the nurse performed a cannula change out by placing the used cannula into a cup.Sterile water was then placed over used cannula for cleaning.The patient was reported to the cough up secretions.Following suctioning of the secretions, sterile water from the cup was used to clear the line.A wire was then noted in the cup which was reported to not have been there prior.It is reported to not be clear as to if the wire had been in the patients inner tube and is concerning that this might have been inside the patients airway.The patient had no reported adverse effects and has been discharged from the hospital.

• Brand Name: PORTEX® UNIPERC® ADJUSTABLE FLANGE TRACHEOSTOMY TUBES
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD.; boundary road; hythe, kent MN CT21 6JL; UK CT21 6JL
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis,, MN 55442 ; 7633833310
• MDR Report Key: 7945041
• MDR Text Key: 123270234
• Report Number: 3012307300-2018-04165
• 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: consumer,distributor,foreign
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/897/080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 123