Consumer reported patient end of pen needle broke off in his stomach during injection.Stated, the issue occurred twice but he does not remember when.Stated, he went to the emergency room but he does not know when and did not have documentation, but he could get it at a later date.Stated, he had 3 x-rays done and he may need surgery.Stated, he can feel the needle in his injection site.Stated, he does not re-use pen needles.Stated, he wants to be compensated for pain and suffering.Stated, he wants to be compensated for being in the emergency room for 8 hours.Discarded the used product hub.Stated, he is going to get a lawyer.Lot: 2348496.Catalog: 320109.Date of event: unknown.Samples: yes, (unused) cl.
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Correction to d2, device product code.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed, and no non-conformances were raised in association with this type of event for this lot.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.
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