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

Model Number	67PFS50
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Nformation received a smiths medical tracheostomy|silicone - bivona tubes neo/ped flextend cuffs do not inflate symmetrically.Unable to use.This was discovered immediately upon usage.No patient adverse events occurred.
Additional Manufacturer Narrative
Other, other text: testing/inspection: sample received: seven (7) samples were received from p/n 67pfs50 l/n 4029499 without their original packaging and with their certificate of decontamination.Functional test: air cuff symmetry test was performed to the units according to mp bivona tt-tj130 rev.102 ? "leak test" and av-10006853 rev.101 - leak testing and cuff symmetry visual aid.Cuff symmetry fixture was used (id: 13.2684-50 due: 02/2022) and rule (id: 13.2893 due: 10/22).Results: when the samples 1,2,4,5,6,7 were inflated with air, the cuff inflated completely.When the sample 3 was inflated with air, the cuff only inflated one side.According to the ifu (10018859-001 rev.100 - instruction for use ? bivona tts flextend tracheostomy)) the pilot balloon was manipulated, and the cuff inflated.After the whole cuff inflated, it was deflated and inflated 4 times, all the times the cuff inflated completely.When measuring the cuff, the percentage for the symmetry was sample 1: 38.8 percent sample 2: 44.4percent , sample 3: 41.6percnet , sample 4: 40.5percnet , sample 5: 40.5percent , sample 6: 40.5percent and sample 7:44.4percent.These results are over 33.3 percent that is the minimum acceptable.Based on the test, the units are within spec.The complaint is not confirmed.Other analysis: the instructive 10018859-001 rev.100 - instruction for use? bivona tts flextend.Tracheostomy?.On section 6.2 says: ?attach a syringe to the pilot balloon and slowly inflate the cuff with 5ml of sterile water.If the cuff does not inflate completely, squeeze the pilot balloon wile gently manipulating the cuff from the shaft.If the cuff still does not inflate, use a new tube, save the old tube and call smiths medical customer service.Deflate the cuff prior to intubations.Mitigation: based on rmd-10001943.100 "fmea for bivona tracheostomy tubes", the process controls for failure mode asymmetrical cuffs are: occurrence: tts cuffs are cut using a cuff chopper fixture and following the procedure mp bivona tt-tj110.113 "flextend tts tracheostomy tube assembly".Detection: production personnel performs a 100percent cuff symmetry test.Quality inspectors takes a representative sample of the lot and performs air cuff symmetry test.Root cause: no root cause could be determined since the complaint was not confirmed since the sample successfully passed the cuff symmetry test.Action taken: no actions taken were performed since the complaint was not confirmed.
Event or Problem Description
Investigation completed and summary in h 10.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 11636660
• Report Number: 3012307300-2021-02958
• Device Sequence Number: 11637060
• Product Code: JOH
• UDI-Device Identifier: 10351688518644
• UDI-Public: 10351688518644
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K92387
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2021

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: No Information
• Device Expiration Date: 07/29/2025
• Device Model Number: 67PFS50
• Device Catalogue Number: 67PFS50
• Device Lot Number: 4029499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 05/01/2021
• Initial Report FDA Received Date: 04/08/2021
• Supplement Report FDA Received Date: 05/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1