The reported event was inconclusive because no sample was returned for evaluation.A potential root cause for this failure could be due to ¿adhesive chemistry not appropriate for application (poor quick stick characteristics)¿.It was unknown whether the device had met specifications.The product was used for treatment purpose.It was unknown whether the product had caused the reported failure.The dhr review could not be performed without a lot number.Based on the results of the investigation, no additional actions are needed.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.Although the product family is unknown, the statlock ifus are found to be adequate based on past reviews.H11: section a through f - the information provided by bard 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 bard.H3 other text : the device was not returned.
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