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), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of an occlusion is unconfirmed as the alleged problem could not be reproduced in the returned sample.One 20 g x 0.75 in.Huber plus infusion set with a valved y-site was returned for evaluation.An initial visual observation showed a small among of use residue on the returned sample.An attempt was made to flush both access points of the returned infusion set with a 12 ml syringe of water.The returned sample was found to be patent to infusion and aspiration and no abnormalities were observed in the flow rate of the infusion set.While no occlusion was found in the returned infusion set, possible causes of resistance during infusion include improper placement of the needle of the infusion set in the implanted port device and occlusion within the implanted port and/or catheter.A lot history review (lhr) of reex0808 showed no other similar product complaint(s) from this lot number.H3 other text : evaluation findings are in section h.11.
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