Model Number 66024007 |
Device Problem
Separation Problem (4043)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2022 |
Event Type
malfunction
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Event Description
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It was reported that an iv3000 1 hand 6x7cm ctn 100 infusion set tape is unmanageable as the thin top piece of tape covering does not peel off easily.As well, the tape gets wrinkled and starts to peel off after bathing.Skin tac or additional strips of another tape had to be used.No other complications were reported.
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Manufacturer Narrative
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Internal complaint reference: case (b)(4).
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Manufacturer Narrative
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Internal complaint reference: case (b)(4).
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Event Description
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It was reported that an iv3000 1 hand 6x7cm ctn 100 infusion set tape is unmanageable as the thin top piece of tape covering does not peel off easily.As well, the tape gets wrinkled and starts to peel off after bathing.Skin tac or additional strips of another tape had to be used.No other complications were reported.
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Manufacturer Narrative
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The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
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Search Alerts/Recalls
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