Catalog Number 515101300010 |
Device Problems
Fitting Problem (2183); Difficult to Open or Close (2921)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/11/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that the pins of a 3.0mm flow coupler would not align.It was further reported the pins were offset and the coupler would not close.This issue was identified during patient use.The device was replaced with no further issues.There was no patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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H10: the device was received for evaluation.A visual inspection was performed, and it was noted that two pins on the right ring of the jaw assembly were bent to varying degrees.This condition of the pins would not allow for the flow coupler rings to align as intended; this would lead to the two rings of the jaw assembly to not closing properly.The reported condition was verified.The cause of the reported condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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Correction: b4/f8: date of this report in the initial mdr is being corrected from blank to 06/07/2021.
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Search Alerts/Recalls
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