It was reported that when pulling the guide to cut the catheter, white dirt with flaking appearance was identified.The catheter was introduced into the patient without complications, but we were concerned if these dirt remained inside the catheter.The problem was evidenced during the passage of the power picc catheter.
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It was reported that when pulling the guide to cut the catheter, white dirt with flaking appearance was identified.The catheter was introduced into the patient without complications, but we were concerned if these dirt remained inside the catheter.The problem was evidenced during the passage of the power picc catheter.
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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 foreign matter is inconclusive due to poor sample condition.Four photo samples of a stylet were provided for evaluation.The stylet is shown outside of patient use and is stored within a plastic bag.The red ¿warning¿ tag is visible near the black tab attached to the stylet.The photos show different angles of the stylet within the plastic bag; however, additional details and information could not be clearly discerned as the wire surface was not clearly visible.The presence of residue could not be determined due to the quality of the photo and lack of a physical sample.A review of the manufacturing records did not reveal any evidence to suggest a manufacturing related root cause contributed to the reported issue.Based on the description of the reported event, possible contributing factors include precipitant formation during flushing and material deposition prior to packaging.Since the complaint could not be confirmed from the images provided, the complaint remains inconclusive at this time.A lot history review (lhr) of redt0801 showed no other similar product complaint(s) from this lot number.
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