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

Model Number	60SP035
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a smiths medical trach tube had an eyelet torn in half.No adverse patient effects were reported.
Additional Manufacturer Narrative
Other, other text: four samples were returned for evaluation.Two of the devices were used samples 1 and 2) and two of the devices were unused (samples 3 and 4).The devices were visually inspected; this showed one cut in the eyelet area for sample 1.No damage was detected on any of the other samples.The manufacturer attempted to induce the condition seen on sample 1.For the first attempt, the investigator tried to induce the damage by not following instructions for neckstrap molding process.The investigator removed the unit from the mold when bushing was still stuck to mold.This test did result in a cut but not in the same area as seen in sample 1.The instructions for use document was reviewed; this showed the several entries that may be relevant to reported issue.From section 4.10: "guard against product damage by avoiding contact with sharp edges.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."based on review of the ifu, it was determined possible that the neckstrap for sample 1 could have occurred during use through the use of a tracheostomy tube holder that had sharp edges.The reported issue was confirmed during examination but the issue could not be attributed to a manufacturing issue.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY TUBE AND CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 11751019
• Report Number: 3012307300-2021-03616
• Device Sequence Number: 11796846
• Product Code: JOH
• UDI-Device Identifier: 15021312000375
• UDI-Public: 15021312000375
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K912469
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2021

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 Model Number: 60SP035
• Device Catalogue Number: 60SP035
• Device Lot Number: 361714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 08/08/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 09/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1