MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. PORTEX BIVONA ¿ TTS¿ TRACHEOSTOMY TUBES; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	67P030
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that the balloon to a smiths medical portex® bivona® tts¿ (tight-to-shaft) tracheostomy tube was not inflating.Trouble shooting methods were performed by the respiratory therapist (rt) with no success.There were no reported adverse effects.
Additional Manufacturer Narrative
One used sample was returned for evaluation.During testing, the operator noted the device cuff would not fully inflate.After the operator manually manipulated the cuff as per device instructions, the device cuff fully inflated.The device instructions include the direction: "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 while 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." the inflated cuff was measured and was found to meet with specifications for cuff symmetry.The manufacturing facility performed a review of the manufacturing process.The review showed that assembly process was being performed as per procedures.This review included the following procedures: basic assembly, manual cleaning and inspection.The manufacturing facility also performed an in-process visual inspection of 32 products that were in the assembly area: this inspection showed no issues with the products being assembled.The root cause could not be established; the returned device was found to meet with specifications.

• Brand Name: PORTEX BIVONA ¿ TTS¿ TRACHEOSTOMY TUBES
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 7759110
• Report Number: 3012307300-2018-03053
• Device Sequence Number: 11201657
• Product Code: JOH
• UDI-Device Identifier: 15021312006254
• UDI-Public: 15021312006254
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2018

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: 11/09/2022
• Device Catalogue Number: 67P030
• Device Lot Number: 3538110
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2018
• Supplement Date Received by Manufacturer: 07/12/2018
• Initial Report FDA Received Date: 08/07/2018
• Supplement Report FDA Received Date: 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1