The device was not returned for evaluation.A potential failure mode could be ¿inadequate connection to syringe¿ with a potential root cause of "improper dimension or tolerancing".The lot number is unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿single use.Do not reuse.Do not resterilize." h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.
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