Catalog Number FT16HN35NGE906N |
Device Problem
Cut In Material (2454)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/05/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The device is currently being evaluated; smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.
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Event Description
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It was reported that a portex® bivona® custom flextend¿ tts¿ neonatal and pediatric tracheostomy tube was tearing at the neck.The incident occurred during insertion and discovered during use.The incident was observed by the patient's family and home health nursing.The tracheostomy tube was used 2-3 times and sterilized by placing in boiled water.It was noted that dale tracheostomy tube ties were used to hold the device.The tracheostomy tube was changed to a new tube when the issue occurred.No patient injury was reported.See mfr: 3012307300-2017-00272 and 3012307300-2017-00273.
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Manufacturer Narrative
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The customer reported that three devices contributed to three reported events (one device per event).The customer returned three devices for evaluation.It could not be determined which device was associated with which reported occurrence; therefore, the evaluation of the three returned devices will be used for the medwatch.Three used bivona® customized tracheostomy tubes were returned for investigation.The devices were received without their original packaging.Visual inspection of the devices found varying degrees cuts/tears on the section of the shaft that connects to the connector.Additionally, it was noted that the wire was exposed on some of the shafts.The observed cuts/tears were found to be consistent with the device being disconnected from the ventilator circuit by pulling or twisting motion rather than using the provided wedge.Investigation determined that the root cause of the cuts/tears was the device being used in a manner inconsistent from the instructions for use.
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Search Alerts/Recalls
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