Model Number SYR, LDR .3CC 31G 100CT5/16" 8/CS |
Device Problems
Contamination /Decontamination Problem (2895); Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/02/2024 |
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 the trueplus single-use insulin syringes.Customer stated that in a new box of the 31g syringes they had found a used syringe with a bent needle.Coordinator had initially spoken with customer; no symptoms or medical attention associated with the use of the product was reported to coordinator.Customer's information had been transferred to technician.Technician was unable to contact the customer via telephone, no further information was able to be obtained.
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Manufacturer Narrative
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Sections with additional information as of; (b)(6) 2024.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.No abnormalities observed with retention samples.Added most likely underlying root cause onto case.Most likely underlying root cause: (b)(6): use error caused or contributed to event.
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Search Alerts/Recalls
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