This report has been identified as b.Braun internal report number (b)(4).A follow-up report will be provided after the examination results are available.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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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 22l16ged9r, leakage between triangle tube and step down tube at big bottom cap was detected.Rework was performed on the batch.After reworked, no such defect was detected at in process and at final control inspection, therefore, this batch was released.Sample/s evaluation: as there are no sample received, further investigation is not possible.The investigation was only done based on picture provided, complaint description and batch manufacturing record review.From the picture provided, the leakage was not able to be identified.According to complaint description and the indication in the figure, the leak observed are between the bag and the tubing, which likely to be referring to the leakage at below bbc (big bottom cap).Reviewing historical date, leakage below the bbc is due to leakage at triangle tube and step down tube connection.An approved project is in place to further address issues with triangle tube and step down tube connection leakage.Analysis: the complaint batch 22l16ged9r was a reworked batch with holdback at in process quality control inspection on failed tightness test due to leaking at step down tube and triangle tube connection.The holdback batch was reworked according to sop hc-my01-m-5-4-16-021 where the old step down tube and tubing were removed and replaced with new step down tube, triangle tube and microbore tube.Assembly of the rework complaint batch was done according to sop elastomeric infusion - final assembly and sop elastomeric infusion system - correction procedure after the batch was reworked, it was tested according to specification (hc-my01-m-5-4-10-601-0) and release after the products are tested to be within specification.The rework process will not have adverse effect to the pump.However, during the rework, the root cause of the complaint defect was still under investigation.Upon the root cause were identified, mitigation actions have been implemented to address the issue.The major contributors of the defect have been immediately rectified after the root causes were identified.Summary of root cause analysis: as neither complaint sample nor meaningful picture was received, further investigation to identify the defect as per customer described is not possible.Therefore, the complaint is considered as not confirmed.However, potential root cause has been identified and an approved project is in place to further address issues with triangle tube and step down tube connection leakage.Cause : cause could not be determine neither sample nor meaningful picture is available for investigation.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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