Model Number PNDL, 5BV TVH TP 31G 8MM100CT 30/CS |
Device Problems
Material Twisted/Bent (2981); No Flow (2991)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/15/2023 |
Event Type
malfunction
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Event Description
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Consumer reported complaint for the trueplus pen needles.Customer stated that the pen needles are not dispensing the insulin or they are bent.Customer had used the whole box and discarded the box.Customer stated that she had 2 other boxes and a few of them had the same issue; customer stated she had discarded one of the other boxes (100 pen needles).The package had not been open or damaged when received by the customer.The customer is using compatible product and the pen needle is aligned properly.At the time of the call the customer felt well and did not report any symptoms.Customer did not claim to be injured while using the pen needles and no medical intervention related to the use of the product was reported.
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Manufacturer Narrative
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Internal report reference number: (b)(4).Additional report reference numbers: (b)(4).Pen needles were not returned for evaluation.Most likely underlying root cause: (b)(6): there was not enough information to determine the mlurc.Note: manufacturer contacted customer in a follow-up call on 03-jan-2024 to ensure the replacement products resolved the initial concern, customer stated they are comfortable with the replacement products.
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Search Alerts/Recalls
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