Model Number SYR, KGR 0.5CC 31G 100CT5/16" 8/CS |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
Insufficient Information (4580)
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Event Date 02/25/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Internal report reference number: (b)(4).Syringes were returned for evaluation.Investigation pending note: manufacturer contacted customer in a follow-up call on 08-mar- 2021 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated initial issue has been resolved.
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Event Description
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Consumer reported complaint for syringes stating that the needle on the 31g syringes bend when aspirating insulin.Customer has been using the product for about two months.Customer stated the box had not been open or damaged when received.The customer feels well and did not report any symptoms.No medical attention associated with the use of the product was reported.The syringe lot manufacturer¿s expiration date is 06/30/2022 and open vial date is two months ago.
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Manufacturer Narrative
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Sections with additional information as of 22-april-2021: h2: device evaluation.H6: updated fda's type of investigation, investigation findings, and investigation conclusions.H10: syringes were returned for evaluation.Reported defect not reproduced.No defect found.Most likely underlying root cause: mlc-061 improper use/mishandle by end user.
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Search Alerts/Recalls
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