MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ULTRAPERC SINGLE STAGE DILATOR TECHNIQUE KI; BTO

Catalog Number 100/563/090

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/17/2022

Event Type  Injury  

Manufacturer Narrative

Other, other text: a product sample was received and is awaiting evaluation and investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.No lot or serial numbers were communicated; device expiration date and device manufacturing date not available.

Event Description

It was reported that patient's subglottic port wasn't working; it had a crack.The nurse attempted to suction the subglottic port.Early intervention was required.The patient wasn't progressing with his decuffing regime; a decision was made by the tracheostomy team to fast patient for a tracheostomy change on day 17.

Manufacturer Narrative

One device was returned, decontaminated and inside of a plastic bag without its original packaging.Visual inspection showed no crack in the subassembly; however, a crack was identified at one end of the cannula.A functional leak test was performed, and the cuff could be inflated without losing air.No root cause could be determined since the complaint was not confirmed due sample provided did not show the failure mode reported.The cause for the crack was user interface.No lot number was provided so a device history record (dhr) review and service history could not be performed.No corrective actions were taken.

• Brand Name: PORTEX ULTRAPERC SINGLE STAGE DILATOR TECHNIQUE KI
• Type of Device: BTO
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15739310
• MDR Text Key: 303140189
• Report Number: 3012307300-2022-26792
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/563/090
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/21/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/25/2023
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention