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 22l01ged8r, which was a reworked batch for 22l01ged81 with holdback at final control inspection on failed tightness test (leaked between step down tube and triangle tube at big bottom cap).Rework was performed on the batch according to sop (b)(4).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 is no sample received, further investigation is not possible.The investigation is only done based on the complaint description and photo provided that indicated the leakage point.The pump was empty and the batch number on the bbc was 22l01ged8r.According to historical data, leakage below the bbc was due to leakage at triangle tube-step down tube connection.Analysis: this complaint batch was a rework batch 22l01ged8r with holdback at final control inspection on failed tightness test due to leak at bottom bbc.The holdback batch was reworked according to sop (b)(4).After the batch was reworked, it was tested according to specification ((b)(4)) and released after the products are tested to be within specification.The rework does not cause any adverse impact to the product.An approved project is in place to further address issues with triangle tube-step down tube connection leakage.However, during the rework, the root cause was under investigation.Upon the root causes were identified, mitigation actions have been implemented to address the issue.The major contributors to the defect have been immediately rectified after the root causes were identified.Summary of root cause analysis : as no sample was received for investigation, and leakage was not able to observed from the received picture, this complaint is not confirmed.However, an approved project is in place to further address issues with triangle tube-step down tube connection leakage.Cause : cause could not be determine no leakage was observed from the picture provided.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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