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.The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged probe cover is confirmed; however, the exact cause is unknown.One probe cover was returned for evaluation.An initial visual observation showed a clear viscous fluid (most-likely ultrasound gel) within the probe cover.Two slits or tears were observed in the probe cover near its distal end.The larger slit was measured to be approximately 2.3 cm long and 1.1 cm proximal to the distal end of the probe cover, and the smaller slit was measured to be approximately 0.6 cm long and 1.7 cm proximal to the distal end of the probe cover.A microscopic observation revealed plastic deformation around the edges of the slits, which were observed to be mostly straight.The corners of the slits appeared to be somewhat pinched.It could not be determined from the evidence observed on the returned sample if the probe cover was damaged prior to, during, or after use.As a note, the product ifu cautions: ¿always snap the needle guide on to the probe hook.Do not slide the needle guide on to the needle guide hook, as the sterile sheath may tear.¿ a lot history review (lhr) of rees1531 showed no other similar product complaint(s) from this lot number.
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