MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX BIVONA MID-RANGE AIRE-CUF ADULT TRACHEOS; TRACHEOSTOMY TUBE AND TUBE CUFF

Model Number	750160
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the pre-use check, the cuff was found stuck to the tube, which did not allow the cuff to be inflated.No patient injury.No additional information is available for this complaint.
Additional Manufacturer Narrative
Samples received: one (1) sample was received from p/n 750160 l/n 3984937 inside its opened original packaging.See pictures below: functional testing: cuff was inflated with 15cc per pwi-10007269 rev.100 ?symmetry and leak test method? and av-10006853.101 ?leak testing and cuff symmetry visual aid? to see if there was any problem to inflate the cuff.Results: sample received is the same as pictures attached, when the cuff was inflated with 15cc of air, the cuff inflated completely and symmetric around the tube.The complaint is not confirmed.No root cause could be determinate since the sample successfully passed the functional test.A dhr review was performed subsequent to the manufacturing of the device and prior to its release.No problems or issues were identified during this dhr review.

• Brand Name: PORTEX BIVONA MID-RANGE AIRE-CUF ADULT TRACHEOS
• Common Device Name: TRACHEOSTOMY TUBE AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): NULL; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 3-10-15, hakata station east,; minneapolis, MN 55442
• MDR Report Key: 13559669
• Report Number: 3012307300-2022-03640
• Device Sequence Number: 11802813
• Product Code: JOH
• UDI-Device Identifier: 15021312006407
• UDI-Public: 15021312006407
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K914088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/12/2025
• Device Model Number: 750160
• Device Catalogue Number: 750160
• Device Lot Number: 3984937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2022
• Supplement Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 06/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown