This report has been identified as b.Braun internal report number (b)(4).Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.Hc-pm complaint processing received no sample and no picture.The following investigations were conducted: visual inspection: no sample was received and thus a further evaluation and investigation of the complaint is not possible.Functional inspection: n.A.Physical inspection: n.A.Summary and assessment: as no sample and no picture was provided for investigation a malfunction could not be detected and therefore the complaint is considered as not confirmed.The complaint is only taken to knowledge and filed for statistical purposes.However, if the complaint sample will be provided, the complaint will be re-opened accordingly.The investigation sample(s) is/are not available.Bmi complaint management statement:- bmi received no sample and no picture for further investigation.Complaint to be forwarded to investigator.
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This report has been identified as b.Braun medical internal report number (b)(4).Root cause analysis: device history record (dhr):- reviewed the dhr for batch 23e27ged41, there is no abnormality and no such defect detected at in process and at final control inspection.Sample/s evaluation: final control flow rate report of affected batch 23e27ged41 was reviewed.For final control flow rate report, the average flow rate deviation from the nominal flow rate was between 5.31% and 10.81%.As no complaint sample was received, further investigation is not possible.Summary of root cause analysis: as no complaint sample was received, further investigation is not possible.Therefore, this complaint is considered as not confirmed.Cause : cause could not be determine as no complaint sample was received, further investigation is not possible.Corrections/containment plans with effective date: not applicable corrective actions with effective date: not applicable justification: not confirmed.Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.
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