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

Model Number	5.0
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/11/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smith medical tracheostomy|silicone - bivona tubes neo/ped aire-cuff malfunctioned while in use with the patient ,the flange tore off.There was no patient injury.The family heard a voice leak sound from the child's throat so the device was checked and the flange was found torn off.The tube had also been raised from the position where it was supposed to be.
Additional Manufacturer Narrative
Other, other text: one silicone - bivona tube was returned.Visual inspection was performed at 12 under normal conditions of illumination in order to detect any damage on the parts.During the visual inspection, we observed that flange is broken.The complaint is confirmed.The occurrence for this failure condition could be caused by a supplier process.The instruction for use indicate that some tracheostomy tube holders contain velcro or metal clips which may have sharp edges.These sharp edges can come into contact with the eyelets and compromise the product integrity.A damaged eyelet can result in decannulation of the tracheostomy tube.We recommend using the twill tape holder supplied with the product.An attempt to produce the failure mentioned on the description of non-conformance by making a small cut in a neckflange eyelet with a blade was performed in two pieces.One piece had the cut on the inside and the other one on the outside.A twill tape cut was used to pull the neckflange by hand; it was possible to reproduce the failure mode.Production personnel inspects the parts 100% before assembling them to see if they have any molding issue such as voids or splits.After the parts are assembled production personnel performs a 100 % visual inspection to see if they have any molding issue such as exposed wire, voids or splits.Quality takes a representative sample and performs a visual inspection for splits/cuts, exposed wire according to procedure.Therefore, according to the instruction for use the occurrence of this failure condition could be caused by: velcro or metal clips from tracheostomy holders which may have sharp edges which can come into contact with eyelets and compromise the product integrity, supplier process related for this occurrence the mitigation to detect this are: when parts are received from supplier, receiving inspection takes a representative sample per lot and performs a visual inspection according to procedure to verify pars are free of damage and molding defects such as sinks, short shots, distortion, cracking or crazing.When parts are molded at, production personnel perform a 100% visual inspection according to procedure to detect short shots, chips or cuts in critical areas.When parts are molded quality personnel take a representative sample per lot and perform a visual inspection according to procedure to short shots, chips or cuts in critical areas.During the manufacturing process parts are 100% inspected before assembling them to see if they have any molding issue such as voids/splits according to procedure.All mitigation's placed were verified and it was confirmed has been executing accordingly, therefore no corrective actions could be implemented, it will be continue monitoring this failure condition in this product for threshold or escalation.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 10402358
• Report Number: 3012307300-2020-08157
• Device Sequence Number: 2949331
• Product Code: JOH
• UDI-Device Identifier: 15021312000337
• UDI-Public: 15021312000337
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K083641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2020

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 Model Number: 5.0
• Device Catalogue Number: 65SP055
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/14/2020
• Supplement Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 08/13/2020
• Supplement Report FDA Received Date: 09/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1