ANGIODYNAMICS INC. ANGIODYNAMICS LOW PROFILE PORT WITH VORTEX TECHNOLOGY; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number CT60LPPDV10 |
Device Problems
Contamination (1120); Melted (1385); Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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Package of port kit intact and sterile, but when opening the kit, one of the stylets had melted plastic, or some kind of debris stuck to it within the sterile packaging.Md was made aware.Kit taken off the sterile field and replaced with a new one and scrub tech changed sterile gloves prior to receiving the new port kit.This port was never implanted into the patient or even touched the patient.Fda safety report id# (b)(4).
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Search Alerts/Recalls
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