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

Model Number	67PFSS45
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign : (b)(6).
Event or Problem Description
Information was received that the cuff on a smiths medical (b)(4) flextend tts pediatric straight neck flange tracheostomy tube was suspected to be leaking as it had to be blocked frequently.No reported medical intervention.No patient adverse effects were reported.
Additional Manufacturer Narrative
Device evaluation: one sample was received from p/n 67pfs45 l/n 3702470 without its original packaging.Sample was received in used condition with its certificate of safe handling.Visual inspection was performed in order to detect any damage on the cuff or airline.No discrepancies were found.The sample was tested on leak test.The test was performed, the unit was inflated, and it was visually inspected no leakage was observed and it was observed that the sample was well inflated.Then the unit was submerged under water,no leakage was observed.It was followed to massage the product, the balloon was squeezed and the airway line was moved back and forth, no leakage was detected.Production personnel performs a 100% leak test during process.Quality inspectors take a representative sample of the lot and performs leak test.The customer reported: was not confirmed.There is no root cause for this event since the complaint was not confirmed.

• Brand Name: BIVONA FLEXTEND TTS PEDIATRIC STRAIGHT NECK FLANGE TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF PRODUCT CODE: JOH
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8672796
• Report Number: 3012307300-2019-03447
• Device Sequence Number: 243515
• Product Code: JOH
• UDI-Device Identifier: 10351688518637
• UDI-Public: 10351688518637
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2019

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: No Information
• Device Expiration Date: 09/18/2023
• Device Model Number: 67PFSS45
• Device Catalogue Number: 67PFSS45
• Device Lot Number: 3702470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2019
• Supplement Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 06/05/2019
• Supplement Report FDA Received Date: 08/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1