Catalog Number 324917 |
Device Problem
Leak/Splash (1354)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/15/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter phone#: (b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
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Event Description
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It was reported that syringe 0.5ml 31ga 6mm 10 bag 500 sla hub separated.The following information was provided by the initial reporter: customer reported that in the last lot purchased, one of the syringes showed the following quality deviation: when removing the orange protective cap, the needle (along with the plastic part) detached itself from the body of the syringe, getting stuck in the orange cap.
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Event Description
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It was reported that syringe 0.5ml 31ga 6mm 10 bag 500 sla hub separated.The following information was provided by the initial reporter: customer reported that in the last lot purchased, one of the syringes showed the following quality deviation: when removing the orange protective cap, the needle (along with the plastic part) detached itself from the body of the syringe, getting stuck in the orange cap.
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Manufacturer Narrative
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H.6.Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 0062085.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification [200880116] noted that did not pertain to the complaint.H3 other text : see h.10.
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Search Alerts/Recalls
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