Model Number SYR, NPD 1.0CC 31G 100CT5/16" 8/CS |
Device Problem
No Flow (2991)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/07/2023 |
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.Complaint was forwarded to supplier quality and internal evaluation was performed by the manufacturer using syringes from the same lot.No abnormalities observed with retention samples.Most likely underlying root cause: mlc-009: use error caused or contributed to event.Note: manufacturer contacted customer in several follow-up e-mails and calls to ensure the replacement products resolved the initial concern - 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.Complaint was initially reported via e-mail and customer was contacted by telephone.Customer stated that the 31g syringes did not properly dispense the insulin.Customer stated that he used multiple syringes attempting to administer the insulin.The package had not been open or damaged when received by the customer.The customer feels well and did not report any symptoms.The customer did not claim to be injured using the syringes.No medical attention associated with the use of the product was reported.
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Search Alerts/Recalls
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