Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.There are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, (b)(4) has been listed and the(b)(4) fda registration number has been used for the manufacture report number.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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H.6.Investigation results: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.A production history review could not be performed, as a valid lot number was not provided.The peura (end user risk analysis) was analyzed to determine the risk to customer.The analysis showed that due to low occurrence, current risk is acceptable.Observations and testing could not be performed because units were not received for investigation of this incident.Conclusions: the defect needle retraction failure; as stated as the reported code could not be identified or confirmed, and cause could not be determined, as the units described in the product incident report were not returned for evaluation and testing.Therefore, there was no physical evidence to confirm or to support manufacturing process related issues for the defect stated in the pir.A formal corrective action will not be initiated at this time.Customer complaint trends are evaluated monthly.If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.
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