MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TUBES CUSTOM; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	FT20GN60NSA036N
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
It was reported only one side of cuff inflated.No additional information.
Additional Manufacturer Narrative
Corrected data: updated event description as no patient was involved.
Event or Problem Description
It was reported only one side of cuff inflated.No patient involvement.
Additional Manufacturer Narrative
Other text: h10: device evaluation: the device was returned for investigation.Visual inspection did not identify any anomalies.Using a syringe, 10 cc of air was inserted into the inflation system.The cuff partially inflated.A portion of the cuff near the distal tip stuck to the shaft (reference picture).Following the instructions under 6.0 set up and use for tts cuffs in the instructions for use, 10018908-001 (formerly pkg-dfu-cfx-2), the cuff fully inflated (reference pictures).The cuff was deflated and inflated multiple times without issue.The device was allowed to rest for six days.The cuff inflated fully without issue.Silicone has the tendency to stick to itself, hence the instructions to unstick a cuff is provided with every device.The investigation determined that there was no defect with the returned device.The customer stated problem was duplicated.The cause of the reported problem was traced to the user manipulation of the device.A dhr review was performed and no problems or issues were identified during this dhr review.
Additional Manufacturer Narrative
Device evaluation: the device was returned for investigation.Visual inspection did not identify any anomalies.Using a syringe, 10 cc of air was inserted into the inflation system.The cuff partially inflated.A portion of the cuff near the distal tip stuck to the shaft (reference picture).Following the instructions under 6.0 set up and use for tts cuffs in the instructions for use, 10018908-001 (formerly pkg-dfu-cfx-2), the cuff fully inflated (reference pictures).The cuff was deflated and inflated multiple times without issue.The device was allowed to rest for six days.The cuff inflated fully without issue.Silicone has the tendency to stick to itself, hence the instructions to unstick a cuff is provided with every device.The investigation determined that there was no defect with the returned device.The customer stated problem was duplicated.The cause of the reported problem was traced to the user manipulation of the device.A dhr review was performed and no problems or issues were identified during this dhr review.

• Brand Name: BIVONA TUBES CUSTOM
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13418853
• Report Number: 3012307300-2022-02310
• Device Sequence Number: 4870892
• Product Code: JOH
• UDI-Device Identifier: 15019517235029
• UDI-Public: 15019517235029
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/25/2022

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: 08/10/2026
• Device Model Number: FT20GN60NSA036N
• Device Catalogue Number: FT20GN60NSA036N
• Device Lot Number: GA020547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2022
• Supplement Date Received by Manufacturer: 01/08/2022; 04/26/2022; 04/26/2022
• Initial Report FDA Received Date: 02/01/2022
• Supplement Report FDA Received Date: 03/17/2022; 05/25/2022; 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2021
• 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