Model Number SYR, NPD 1.0CC 29G 100CT1/2" 8/CS |
Device Problems
Manufacturing, Packaging or Shipping Problem (2975); Material Protrusion/Extrusion (2979)
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Patient Problems
Bruise/Contusion (1754); Pain (1994)
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Event Date 09/20/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Internal report reference number: (b)(4).Syringes were not returned for evaluation.Note: manufacturer contacted customer in several follow-up calls to ensure the initial concern is resolved - unable to establish contact with customer at this time.
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Event Description
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Consumer reported complaint for syringes.Wife is calling on behalf of the customer.Customer had purchased 100 count of the 29g syringes and stated some appear to have an extra piece of metal sticking out of them.Customer stated they have "barbs" that catch his skin when he uses them, and that they hurt and bruise his skin.No medical intervention related to the use of the syringes was reported.At the time of the call the customer felt well and did not report any symptoms.The package had not been open or damaged when received by the customer.
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Manufacturer Narrative
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Sections with additional information as of 04-jan-2022 h6: updated fda's type of investigation, investigation findings, and investigation conclusions.H10: syringes were not returned for evaluation.Complaint was forwarded to supplier quality based on complaint's description for investigations, no product was returned to thi, internal evaluation has been completed by the manufacturer, reported defect not reproduced on retention samples.Most likely underlying root cause: mlc-009: user error caused or contributed to event.
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Search Alerts/Recalls
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