Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation - unknown.The actual device was not returned to the manufacturing facility for evaluation.Based from the results of our investigation, the root cause of the complaint could not be identified.The condition of the actual sample was not confirmed since it was not returned for evaluation.Retention samples were confirmed free from defects that will affect activation of safety sheath.Related functional testing such as sheath radial strength, sheath activation and deactivation were all passed.In addition, the safety sheath was successfully activated without any difficulty during simulation.We have series of visual in-process inspection to detect abnormality on the sheath that may lead to problem during sheath activation.Molding condition of the components critical to the safety activation of the product is routinely checked to assure that no defects will be encountered that will lead to sheath activation problem.Similarly, the assembly status of the safety needle such as sheath collar fitting and damaged parts that will affect product function is being confirmed.Lot history file revealed no related nonconformity or irregularity that will lead to the complaint.Prior shipment, qc conducts outgoing visual, sensory, and functional inspection to assure lots are in good quality.All samples passed.(b)(4).
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The user facility reported that the safety cap on the needle did not properly engage, leaving the top portion of the needle exposed resulting to a needlestick.The nurse was stuck with the needle due to this issue.The safety cap on the needle does not properly engage which leaves the top portion of the needle exposed.There was no known impact on the patient.There were no other devices or equipment used with the reported product.Additional information was received 13december2019: when the employee tried capping the safety device, it flopped back.A lot of pressure had to be used to close them.The needle was not bent prior to activation.Procedure was completed successfully.Diagnostic testing was performed per facility protocol.
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