Catalog Number 305283 |
Device Problems
Retraction Problem (1536); Physical Resistance (2578); Noise, Audible (3273)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/18/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported during use of the bd integra¿ syringe ¿it was hard to push and when 0.2ml of medication remained in the syringe it made a clicking noise while retracting the needle.When removed from patients arm the needle had not retracted.There was no report of injury or medical intervention.
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Manufacturer Narrative
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Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Dhr review could not be performed due to unknown batch #.Investigation conclusion: root cause and capa not required as no defects were confirmed.
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Search Alerts/Recalls
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