The device was returned for evaluation, and medline renewal confirmed that the tip of the device was missing.We were not able to obtain enough information to determine the root cause of the failure.However, information regarding the incident indicated that the patient was not harmed.In addition to the device evaluation, our investigation also included a review of the manufacturing process.We reconfirmed that all processes were conducted as required, and that the device met all the inspection requirements prior to packaging and release.The instructions for use state that the tip of the device may break if excessive force is applied, and that the use of excess force to pass the needle through fibrous/calcified tissue, or striking bone, can cause needle breakage and patient injury.It is recommended to reposition the needle to pass through a different area.Even though the location of the missing piece is not known, we are filing this medwatch report in an abundance of caution.This medwatch report was originally submitted on (b)(6) 2016, however due to an internal error, this report was submitted through the esg test account instead of the esg production account.Consequently, cdrh did not receive this report within the 30 day timeframe.Therefore, this medwatch report now reflects today's date which corresponds with the file transmission through the esg production account.
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A customer reported that the tip of a reprocessed mutlifire scorpion needle broke off during use, and that the broken piece was not recovered.The location of the broken piece is not known, and the user did not confirm whether or not the piece was left in the patient.Information regarding the incident indicated that the patient was not harmed in any way.However, in an abundance of caution, medline renewal is filing this medwatch report.
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