Root cause: a true root cause cannot be determined as a sample was not returned for evaluation and a lot number was not provided.A possible root cause of an assembly error was identified.Corrective action: supervisors were made aware of the reported incident through a notification memo.Investigation summary: an internal complaint (call (b)(4) was received indicating that a deroyal convenience kit (part number 89-6015) was in use in a procedure when the needle count was found to be off by one.The end user found two needles stuck together, which caused the count to be over by one needle.A lot number for the affected kit was not provided.The customer was contacted to obtain a lot number.However, the customer reported the kit had been discarded and no lot number could be identified.Additionally, a sample was not returned for evaluation.The complaint investigator reviewed the bill of material for the finished good and found it lists one needle each.Therefore, the count in the finished good should have been one needle.The inventory of the raw material needle was checked and no needles were found stuck together.Preventive action: due to the root cause determination, a preventive action has not been taken.The investigation is complete at this time.If new and critical information becomes available, this report will be updated.
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