MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA CUSTOMIZED TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	FP22JN40NSF099N
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a custom pediatric tracheostomy tube with a cap was not holding pressure.The cuff gradually deflates after one hour.The customer puts a cap on the cuff to stop it.Patient is using two (2) tubes interchangeably, but cuff is leaking.The customer is unable to send them back until replacement devices for the patient to use are received.No injury reported.
Additional Manufacturer Narrative
One patient, two product malfunctions.(b)(6) and (b)(6) both represent the same patient.This is the first malfunction report for the related complaints.Date of event, lot number, udi section, expiration date, device manufacture date are unknown.No information has been provided to date.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.
Additional Manufacturer Narrative
Other, other text: g1,2 email is: regulatory.Responses@icumed.Com.Device evaluation: no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.Although no lot number was provided, there have only been two lots ordered by this customer, prior to the complaint date: gb001267 and gb003261.There were no non-conformance reports issued for either lot.

• Brand Name: BIVONA CUSTOMIZED 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): NULL; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16482458
• Report Number: 3012307300-2023-02001
• Device Sequence Number: 7482125
• Product Code: JOH
• UDI-Device Identifier: 15019517320268
• UDI-Public: 15019517320268
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2023

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 Model Number: FP22JN40NSF099N
• Device Catalogue Number: FP22JN40NSF099N
• 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: 02/13/2023
• Supplement Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 03/03/2023
• Supplement Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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