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

Model Number	750170
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that the device cuff is faulty in the set.No patient involvement.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product sample was received.Review of provided photos shows an air cuff with a small portion stuck to itself.There are no details in the complaint description to suggest that the complainant attempted to massage the cuff to unstick the portion of the cuff that was stuck to itself.Since the device was manufactured in 2018, and this was the first time used it is likely time and temperature contributed to a small portion of the cuff sticking to itself.The investigation did not identify a manufacturing defect.No corrective actions are planned at this time.If the product is returned, the manufacturer will reopen this complaint for further investigation.This remediation mdr was generated under protocol (b)(4) as a result of warning letter cms# (b)(4).

• Brand Name: BIVONA TUBES ADULT AIRE-CUF
• 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): NULL; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; arayidathupalam; minneapolis, MN 55442
• MDR Report Key: 15620459
• Report Number: 3012307300-2022-24614
• Device Sequence Number: 6225275
• Product Code: JOH
• UDI-Device Identifier: 15021312006414
• UDI-Public: 15021312006414
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K914088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2023

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: 10/24/2023
• Device Model Number: 750170
• Device Catalogue Number: 750170
• Device Lot Number: 3712390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2022
• Supplement Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 10/17/2022
• Supplement Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2018
• 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