Model Number MP1000-C |
Device Problems
Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported maxplus positive pressure connector was damaged, causing leakage.The following information was provided by the initial reporter, translated from chinese: "the head nurse of the nicu department reported that the needleless infusion connector was cracked during use, causing fluid leakage.".
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Event Description
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It was reported maxplus positive pressure connector was damaged, causing leakage.The following information was provided by the initial reporter, translated from chinese: "the head nurse of the nicu department reported that the needleless infusion connector was cracked during use, causing fluid leakage".
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Manufacturer Narrative
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H.6.Investigation: one mp1000-c china sample was received without packaging for investigation.The customer feedback indicates the complaint sample was from lot 20015137.No further information was available to assist the investigation in this instance.A visual inspection of the received sample confirmed the customer's experience as a crack was identified on the female luer adaptor of the maxplus component; leakage was observed from the crack.A review of the production records for lot 20015137 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The type of crack observed can be caused or contributed to by a combination of different factors, including over-torque of the component during connection with the male luer, use of a male luer that is not compliant to iso standards, or prolonged use of substances that are aggressive to plastics.From the information available it is not possible to speculate which of these factors were key contributors to the reported issue.H3 other text : see h.10.
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Search Alerts/Recalls
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