Catalog Number 828155 |
Device Problems
Off-Label Use (1494); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Improper Flow or Infusion (2954); Infusion or Flow Problem (2964)
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Patient Problem
Skin Inflammation/ Irritation (4545)
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Event Date 09/08/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Trend analysis and production records investigated for lot 56705a, no abnormalities found.The root cause of the complaint found to be due to intentional unintended use of device.
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Event Description
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A case manager from a syringe exchange program relayed the information that the syringe users are reporting skin irritation, burrs and plunger suction difficulties.Due to the syringes being used for unintended use as indicated by the reporter, the syringes are not malfunctioning.
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Event Description
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A case manager from a syringe exchange program relayed the information that the syringe users are reporting skin irritation, burrs and plunger suction difficulties.Due to the syringes being used for unintended use as indicated by the reporter, the syringes are not malfunctioning.
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Manufacturer Narrative
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Retained lot samples for syringe lot 56705a were tested for needle sharpness and plunger slip.No abnormalities were found during testing.
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Search Alerts/Recalls
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