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

Model Number 100/897/090CZ

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

Information was received that a smiths medical portex uniperc adjustable flange cuffed tracheostomy tube cuff leaked near the base of the tracheostomy (trach) tube immediately on use.No clinical consequences to the patient were reported.

Event Description

Additional information was received that a tracheostomy (trach) change out was required.

Manufacturer Narrative

One tracheostomy was returned evaluation.Visual inspection of the device found it to be in good physical condition.During the manufacturing process the uniperc devices are 100% inflation tested.The inflation test was used as functional testing on the returned sample.After 12 hours, the cuff was noted to be significantly deflated.The sample was then submerged under water, and cuff was inflated using a syringe.Air was observed to be leaking from the place where inflation line is connected with the inflation lumen.The most probable cause of issue was determined to be that the flange was pulled above the last marking, puncturing the lumen.It was determined that the reported customer complaint has been confirmed.

• Brand Name: PORTEX UNIPERC ADJUSTABLE FLANGE CUFFED TRACHEOSTOMY TUBE
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8186332
• MDR Text Key: 131069159
• Report Number: 3012307300-2018-08913
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019315107214
• UDI-Public: 15019315107214
• Combination Product (y/n): N
• PMA/PMN Number: K083031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/12/2022
• Device Model Number: 100/897/090CZ
• Device Catalogue Number: 100/897/090CZ
• Device Lot Number: 3431839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2019
• Date Manufacturer Received: 03/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention