(b)(6).Device was not implanted.The actual device was disposed; however, an unused sample is available for return to the manufacturing facility.Therefore, the investigation was based upon evaluation of user facility information and retention samples of the involved product code/lot# combination.Based from the results of our investigation, the root cause of the complaint could not be identified.We have checked and verified the retention samples and confirmed free from any deformities such as bent, tilted and other damages on cannula which could result to broken needle.No holes, cracks, short shot or any molding related defects were also noted.Retention samples were further evaluated through sheath activation and deactivation and manual sheath activation.All samples had passed.We also conduct production in-process inspection, no nonconformity noted.Prior shipment, qc conducts outgoing inspection to assure lots are in good quality.All samples passed.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.(b)(4).
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This report is being submitted as follow up no.1 to provide the device return date and to provide the completed investigation results.The unused samples have been returned to the manufacturing facility for evaluation.Same lot samples received consisted of 20 pieces unopened sg3 needles.The same lot samples visually inspected and confirmed free from any deformities which could result to broken needle.These samples were also evaluated through sheath activation and deactivation using autograph machine.All are within specification.They were also evaluated for cannula stiffness test and resistance to breakage test with passed results.In addition, sensory confirmation through manual activation are also passed.The cannula is fully engage and no broken cannula encountered during manual activation.Based on the results of our investigation, the root cause of the problem could not be identified since condition of the actual sample was not confirmed.There is no evidence that this event was related to a device defect or malfunction.
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This report is being submitted as follow up no.1 to provide the device return date and to provide the completed investigation results.The unused samples have been returned to the manufacturing facility for evaluation.Same lot samples received consisted of 20 pieces unopened sg3 needles.The same lot samples visually inspected and confirmed free from any deformities which could result to broken needle.These samples were also evaluated through sheath activation and deactivation using autograph machine.All are within specification.They were also evaluated for cannula stiffness test and resistance to breakage test with passed results.In addition, sensory confirmation through manual activation are also passed.The cannula is fully engage and no broken cannula encountered during manual activation.Based on the results of our investigation, the root cause of the problem could not be identified since condition of the actual sample was not confirmed.There is no evidence that this event was related to a device defect or malfunction.
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