H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.6/20/2019 - the following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of foreign material contained within the powerglide assembly was confirmed and the cause appeared to be manufacturing-related.The product returned for evaluation was one 18ga x 10cm powerglide pro midline catheter assembly.The sample was received in its original sealed packaging.The device was removed from the packaging.During gross inspection of the device, red strand-like material was observed between the catheter and the needle shaft.The material was removed and examined using a digital microscope.The material appeared to be a fiber or suture-like material.The position of the material and the discovery upon removal from its sealed packaging indicated that the material was deposited during device assembly.
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