(b)(4).
No samples were returned, but picture of a capillary of an introcan safety-w pur 20g, 1.
1x32mm-ap has been provided.
From the picture provided, the capillary was observed to be cut off.
Further investigation will be done based on photo given.
From the observation on the received picture the used capillary hub has shorter length of the capillary.
The cut off part of capillary cannot be seen in the picture and the surface of the torn off area was not visible.
Cut off capillary most likely not appear to be attributed by manufacturing process as the defect is able to be detected and reject by the in-line vision system.
Damages induced after assembly process is not possible since the catheter had been protected with protective cap.
Since no defect samples provided, no further investigation can be carried out thus this complaint will be concluded as not confirmed.
This complaint will be filed for statistical purpose.
Device history record review (dhr): reviewed the device history record for batch number 19b27g8271 and no abnormalities found during in process and final control inspection.
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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