Model Number 3600-100 |
Device Problem
No Apparent Adverse Event (3189)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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A follow up report will be submitted upon the completion of the investigation into this event.(b)(4).Device not returned.
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Event Description
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Medwatch received from fda that the user facility (uf # (b)(4)) reported the drain connector tubing caps missing from the tubing assembly.Hospital had issues with it coming loose with normal handling and causing the exposed tubing tip to touch the floor or wall thus causing us to reopen another package.
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Manufacturer Narrative
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Based on the results of the investigation the removal of the tube set caps was part of a company initiative to enhance the clinician experience, reduce our carbon footprint and reduce waste.
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Search Alerts/Recalls
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