Lot Number UNKNOWN |
Device Problem
Moisture or Humidity Problem (2986)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(6).The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.(b)(4).
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Event Description
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It was reported that prior to use of the intra-aortic balloon (iab), 55 catheters appeared to have moisture inside the packaging.There was no patient involvement.This report is for #45 of the 55 devices.
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Manufacturer Narrative
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Initially reported; it was reported that prior to use of the intra-aortic balloon (iab), 55 catheters appeared to have moisture inside the packaging.There was no patient involvement.This report is for #45 of the 55 devices; corrected to; it was initially reported that were 55 intra-aortic balloons (iab) catheters.This is being corrected to 41 catheters.Initial report of #45 of the 55 (this report) is being cancelled.Complaint # (b)(4), record id # (b)(4).
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Event Description
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It was initially reported that there were 55 intra-aortic balloons (iab) catheters.This is being corrected to 41 catheters.Initial report of #45 of the 55 (this report) is being cancelled.
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Search Alerts/Recalls
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