Model Number SYR, NPD 0.5CC 30G 100CT5/16" 8/CS |
Device Problem
Defective Component (2292)
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Patient Problem
Pain (1994)
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Event Date 02/21/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Internal report reference number: (b)(4).Additional report reference number: (b)(4).Syringes were returned - product evaluation in-process.Note: manufacturer contacted customer in several follow-up 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 via telephone.Customer stated that the plunger on the 30g syringes were not working correctly.Customer stated that he has to push the plunger harder than usual in order to administer the insulin, and as a result, the syringe needle was causing him pain.The customer has used more than half of the syringes.The syringes are expired: manufacturer¿s expiration date is 08/09/2023.Customer stated he is having the same issue with another lot of the syringes, internal report reference (b)(4).The customer feels well and did not report any symptoms.No medical attention associated with the use of the product was reported.
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Manufacturer Narrative
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Sections with additional information as of 11-apr-2024 updated fda's type of investigation, investigation findings, and investigation conclusions complaint was forwarded to supplier quality based on complaint's description for investigations.Customer returned used syringes; unable to ship to the manufacturer and expired.Scrap returned product.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: mlc-012: product expired.
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Search Alerts/Recalls
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