This report has been identified as event one of b.Braun internal report number 400494684.We received no sample nor some relevant / significant pictures for investigation.Therefore, an examination / root cause analysis was not possible.Retained sample investigation: 1.Functional test no abnormality was identified.Bending stiffness test was conducted on the retention sample of cannula tubes in accordance with the valid testing and measuring method.Inspected item: pencan 25gx4 w.Intro.-eu/ap material no.: 4502116-13xx batch no.: 20d21h8b05 result: 0.381 mm judgement: passed conditions of testing: span: 10.0 mm test load: 7.0 n specification: max 0.43 mm (thin walled tubing) 2.Review manufacturing records we investigated our manufacturing records of the concerned batches of bulk needles, but any abnormality was not found.3.Justification this complaint was not confirmed.We received no complaint sample.Therefore, we conducted the review of the manufacturing record of the concerned batch of the bulk needle.Also, the visual inspection and the bending stiffness test for the cannula tubes using the retention sample were performed accordingly.Result any abnormality was not confirmed as a result of reviewing the manufacturing record of the bulk needle.No abnormality was identified as a result of the visual inspection of the retention sample.Result: 0.381 mm specification: max 0.43 mm (thin walled tubing) span: 10.0 mm test load: 7.0 n judgement: passed it was confirmed that the inspected samples satisfied the specification of the bending stiffness.Note: this report is being filed for an item number that is not sold in the united states, however this item or similar items are sold in the united sates by b.Braun medical, inc.
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