Device Problems
Product Quality Problem (1506); Material Too Rigid or Stiff (1544); Dull, Blunt (2407); Material Integrity Problem (2978)
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Patient Problem
Pain (1994)
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Event Date 11/01/2023 |
Event Type
malfunction
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Event Description
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End user reports that the cannulas on syringe lots 59693 expiration date 04/09/20207 and 58196a expiration date 01/18/2027 have burrs and the needle is catching the skin causing them pain.User also reports that the plunger is easily removed from the barrel.
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Manufacturer Narrative
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Initial trend analysis for lots 59693 and 58196a was conducted, no malfunctions were found.This is the only complaint for lots 59693 and 58196a.Further investigation will be conducted to determine the root cause of complaint.
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Event Description
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End user reports that the cannulas on syringe lots 59693 expiration date 04/09/20207 and 58196a expiration date 01/18/2027 have burrs and the needle is catching the skin causing them pain.User also reports that the plunger is easily removed from the barrel.
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Manufacturer Narrative
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Cmo inspected retained lot 58196a, no abnormalities were found during testing.
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Search Alerts/Recalls
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