Catalog Number 20060E7D |
Device Problems
Complete Blockage (1094); Restricted Flow rate (1248)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/19/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that bd smartsite¿ needle-free connector extension set was blocked.The following information was provided by the initial reporter: " extensions that stick together when clamped.Impossibility of infusing the treatments (acupan, paracetamol, rocéphine and gv) because they remain stuck.".
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Manufacturer Narrative
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The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 9/7/2021.H.6.Investigation: one 20060e7d sample was received without packaging for investigation; residual fluid was present in the line.The customer feedback indicates the sample was from lot 19066544.A visual inspection of the returned sample confirmed the customer's experience as a kink was identified in the tubing immediately upstream of the male luer component.A closer inspection identified the tubing appeared cloudy white at the location of the kink.No flow restrictions or occlusions were identified during functional testing.An attempt to manipulate the kink was made however the tubing did not return to it's normal shape and the kink remained.The details of this feedback were forwarded to the manufacturing site for investigation.In this instance, a definitive root cause for the reported flow restriction could not be identified as the reported kinked tubing did not impact the flow rate of the infusion set.The customer's experience of kinked tubing is likely to have occurred as a result of inadequate coiling of the set during the packaging process.During sterilization, the products are exposed to an elevated temperature and multiple vacuum cycles which can cause the product to become pressed into this position and retain the kinked shape.This is a manual process and it is likely to have occurred due to human error.A review of the production records for lot 19066544 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.
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Event Description
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It was reported that bd smartsite¿ needle-free connector extension set was blocked.The following information was provided by the initial reporter: " extensions that stick together when clamped.Impossibility of infusing the treatments (acupan, paracetamol, rocéphine and gv) because they remain stuck.".
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Search Alerts/Recalls
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