C.R. BARD, INC. (BASD) -3006260740 POWERLOC SAFETY INFUSION SET 20G X 1IN; SET, ADMINISTRATION, INTRAVASCULAR
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Model Number N/A |
Device Problems
Contamination (1120); Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/15/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
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Event Description
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It was reported that "during the run-in of chemotherapy, the tubing came loose from the luer lock piece, creating a spindle.Fortunately, this was noticed by the patient in time and worse was prevented.We no longer have the product itself because it was contaminated with cytostatics.".
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Event Description
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It was reported that "during the run-in of chemotherapy, the tubing came loose from the luer lock piece, creating a spindle.Fortunately, this was noticed by the patient in time and worse was prevented.We no longer have the product itself because it was contaminated with cytostatics.".
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Manufacturer Narrative
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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 batch history, applicable previous investigation(s), labeling, applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a detached hub is confirmed but the exact cause remains unknown.Three photo samples of a powerloc infusion set were provided for evaluation.The first photo shows the proximal end of the extension tubing.The clamp is present over the tubing; however, the luer hub is not attached.The second photo shows a complete view of the powerloc device without the luer hub.The characteristics of the extension tubing cannot be clearly observed from the two images.The third image shows the luer hub attached to a three-way valved infusion hub device.A portion of the extension tubing does not appear to be present within the luer hub which suggest a break in the tubing did not occur.Based on the photos provided, possible contributing factors include excessive tensile force and damage during handling.Since the hub was observed to be detached from the extension tubing, the complaint is confirmed.H3 other text : evaluation findings are in section h.11.
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