MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA; NEO PEDS

Model Number	67SP035
Medical Device Problem Codes	Leak/Splash (1354); Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smiths medical tracheostomy|silicone - bivona tubes neo/ped tts were reporting two pediatric trachs were being tested for procedure.The patient was being changed from a 4.0 peds shiley uncuffed to this trach type and size.Patient is (b)(6) year old, 24/7 trach and vent dependent.Both of the cuffs were not inflating.With manipulation, one of the cuffs was able to inflate and be inserted into the patient.Despite the same manipulation on the other cuff, it was not inflating at all.
Additional Manufacturer Narrative
Other, other text: additional information was received from the customer indicating that the fault was found at a routine tracheostomy tube change.The information also includes that the fault did not impact the patients? airway.One bivona tracheostomy tube was returned for analysis in used conditions.No damage was noted upon visual inspection.The sample was inflated with air; the pilot balloon inflated but air was stuck in it.Relevant documents were reviewed and deemed adequate.The pilot balloon was manipulated, and the cuff inflated to one side.The cuff was manipulated again, and the entire cuff inflated.Inflation and deflation of the cuff was performed four times; no inflation issues observed.Based on the evidence, the complaint was not confirmed as no fault was found.

• Brand Name: BIVONA
• Common Device Name: NEO PEDS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 10409623
• Report Number: 3012307300-2020-08205
• Device Sequence Number: 3001321
• Product Code: JOH
• UDI-Device Identifier: 15021312000719
• UDI-Public: 15021312000719
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K014088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2020

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: 11/01/2024
• Device Model Number: 67SP035
• Device Catalogue Number: 67SP035
• Device Lot Number: 3901311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/17/2020
• Supplement Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 08/14/2020
• Supplement Report FDA Received Date: 09/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 3 YR