The user facility reported that the needle detached from the butterfly surflo winged infusion set ,and stayed in the patient's arm post infusion procedure.Additional information was received on 16oct2020.The patient was receiving end of life treatment in hospice care.The sv device was placed on (b)(6) 2020 for sub-q medication delivery at the left upper scapula.The patient was restless; however, the night nurse did not note anything unusual at bandage site.The needle was discovered to be missing on (b)(6) 2020, when the sub-q site was being discontinued.X-ray confirmed the needle to be 3.5cm from the site.They are not removing the needle since patient is at end of life, and removal would cause more harm than leaving it where it is.They confirmed the needle (steel) was not broken, however, had slipped cleanly out of the butterfly.
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The actual sample was returned for evaluation.The needle was confirmed to have been removed from the wing part, and no needle was received.Upon checking the glue mound at the connection part between needle tube and hub, the glue remained, and no irregularity was observed in the glue amount.Two retention samples were visually checked, wherein no irregularity including detachment of needle tube or the defect that may cause needle detachment was observed.The bonding strength between needle tube and hub was measured and the results for both samples were shown to have met the manufacturer's specification.A review of the manufactruing records of the product code/lot# combination was conducted with no findings.Furthermore, the sampling test results were reviewed and no irregularities related to the glue amount and bonding strength of the needle tube were detected.Based on the investigation, it is presumed that greater stress than allowable limit has been applied to the actual sample.However, the exact root cause was unable to be identified, since no irregularity was found in the manufacture inspection records and our retention samples.
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