MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA UNCUFFED NEONATAL AND PEDIATRIC FLEXTEND PL; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	67PFSS30
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during pre-test, two cuffs were not inflating.No patient injury was reported.
Additional Manufacturer Narrative
Two (2) samples were received in used conditions, without their original packaging and with their certificate of decontamination.Functional test: samples were filled with 5cc of air ? "leak test" to see if there was any functional problem.When the samples were inflated with air, the pilot balloon inflated but all the air was stuck it.According to the ifu (10018859-001 rev.100 - instruction for use ? the pilot balloon was manipulated and the whole cuff inflated.After the whole cuff inflated, we deflated and inflated 4 times, all the times the cuff inflated completely and symmetrically.The complaint was not confirmed.The root cause could not be determined since the sample successfully passed functional test.No corrective actions were taken since the complaint was not confirmed.A device history record review was not conducted, based upon review of the information provided by the customer, as it does not indicate a problem with the initial manufacture or prior repair of the device.(b)(4).This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: BIVONA UNCUFFED NEONATAL AND PEDIATRIC FLEXTEND PL
• 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; minneapolis, MN 55442
• MDR Report Key: 15436662
• Report Number: 3012307300-2022-19370
• Device Sequence Number: 5673260
• Product Code: JOH
• UDI-Device Identifier: 10351688518675
• UDI-Public: 10351688518675
• Combination Product (Y/N): N
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2022

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: 11/04/2025
• Device Model Number: 67PFSS30
• Device Catalogue Number: 67PFSS30
• Device Lot Number: 4075246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2022
• Initial Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2020
• 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