COVIDIEN LLC DELTA VALVE, NEONATAL, PERFORMANCE LEVEL 1.0; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
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Model Number 27219-1 |
Device Problem
Device Misassembled During Manufacturing /Shipping (2912)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/26/2020 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that it seemed that the ventricular connection site was much shorter than it was supposed to be.The facility was currently ceasing all use of the valves.Additional information received reported that just by looking at the valve in the sterile packaging, there was a distinct difference between the two connectors.The distal connector was much longer than the proximal connector.
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Search Alerts/Recalls
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