MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX BIVONA FLEXTEND TTS PEDIATRIC STRAIGHT NECK FLANGE TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	67PFS35
Medical Device Problem Codes	Fluid/Blood Leak (1250); Malposition of Device (2616); Device Dislodged or Dislocated (2923); Unintended Movement (3026)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot number: lot number was reported as unknown, but upon deceive receipt, the lot number was noted as 3802153.Related to mfrs (same patient with multiple occurrences): 3012307300-2019-05555, 3012307300-2019-05556.
Event or Problem Description
Information was received that a smiths medical portex bivona flextend tts pediatric straight neck flange tracheostomy tube was in use with a patient at their home for several days.The patient's mother reported that water from the cuff kept leaking back into the pilot balloon and then the tube came out on its own.It was stated this happened three times.There were no adverse patient effects.The reporter also noted no medical intervention was required.
Additional Manufacturer Narrative
Device evaluation: one bivona sample was received for evaluation in used condition and without its original packaging inside a ziploc bag.Visual inspection found loose contamination on the unit.Next, the sample was filled with 5cc of air for functional testing.When inflating the unit with air, the cuff inflated without problems.No leaks were found.Upon further leak testing the device was inflated, and it was visually inspected for 10 seconds, and observed to be well inflated.Subsequently, the unit was submerged under water, no leakage was observed.Next, the investigator massaged the product and the balloon was squeezed where the airway line moved back and forth, and no leakage was detected.Furthermore, no leaks were found when the device was filled with 5 cc of water.Additionally, the airway line assembly and balloon assembly were reviewed with no discrepancies and were audited during thirty two (32) units finding no deflated/incorrectly inflated cuffs.A review of the manufacturing process was conducted and was considered adequate and correct.Based on the evidence and testing, the complaint was not confirmed.No fault was found with the returned sample.

• Brand Name: PORTEX BIVONA FLEXTEND TTS PEDIATRIC STRAIGHT NECK FLANGE TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9176492
• Report Number: 3012307300-2019-05554
• Device Sequence Number: 16798178
• Product Code: JOH
• UDI-Device Identifier: 10351688518613
• UDI-Public: 10351688518613
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2019

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: Lay User/Patient
• Device Expiration Date: 03/27/2024
• Device Model Number: 67PFS35
• Device Catalogue Number: 67PFS35
• Device Lot Number: 3802153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2019
• Supplement Date Received by Manufacturer: 11/10/2019
• Initial Report FDA Received Date: 10/10/2019
• Supplement Report FDA Received Date: 12/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1