MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA AIRE-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY 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	09/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a pre-use check, the customer noticed the cuff did not inflate.No patient injury was reported.
Additional Manufacturer Narrative
Four (4) pictures and one (1) sample were received.In first and second pictures it was observed the original labelling.In third and fourth pictures that cuff is sticking to the tube was observed.The sample was received in unused conditions inside its closed original packaging.Sample was filled with 15cc of air in order to see if there was any functional problem.The unit was inflated with air, the cuff stuck to the tube.The complaint is confirmed.The most probable root cause is cause by the machine error or operator incorrect set-up.Mitigation has been put in place to detect a machine error.All mitigations on placed were verified and it was confirmed and it has been executed according, therefore no corrective actions could be implemented.This failure will continue to be monitor in this product for threshold or escalation.Operator of device is unknown.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: BIVONA AIRE-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 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: 15446297
• Report Number: 3012307300-2022-19628
• Device Sequence Number: 7529826
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/19/2022

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
• Device Expiration Date: 10/23/2024
• Device Model Number: 750160
• Device Catalogue Number: 750160
• Device Lot Number: 3897746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 09/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown