H10: manufacturing review: the lot number was not provided; however, the manufacturing process was reviewed.Based on the results of the manufacturing review, it was concluded that contamination on the complaint products could be related to the nature of parts and manufacturing process of probe products.The products have been 100% inspected to remove contamination however, additional operator training was conducted to ensure awareness and focusing on the product contamination in their operations.Investigation summary: the physical device was not returned for evaluation.One biohazard bag was received with an unknown substance/material.The material was inspected via microscopic imaging and appeared to be amber in color with a jelly like consistency, containing fibers within along with what appears to be blue flecks.The material was further inspected via ftir/sem analysis.The analysis concluded the returned material composition was consistent with pe (polyethylene, pet (polyethylene terephthalate), silicone, dispersant (such as drewsperse s-825), and 300 series stainless (such as 304 stainless) with some aluminum (ai) detected which may be the result of metal transfer as the material is not consistent with stainless.Although the ftir/sem analysis concluded material composition consistent with materials used in the build of this device, neither the physical device nor a photo identifying the alleged foreign material were provided; therefore the investigation is inconclusive.The returned material could potentially be a result of handling and usage by the end user or related to the nature of parts and manufacturing process of probe products.Based on the provided information, the foreign material like fuzz was found and removed from the device and unknown if the foreign material was potentially contaminated with any other materials prior to evaluation.A definitive root cause for the reported issue could not be determined.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.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.H3 other text : device not returned.
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