Model Number PNDL, 5BV TVH TP 32G 4MM100CT 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 05/04/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Internal report reference number: (b)(4).Pen needles were returned - customer had returned used pen needles, unable to ship to manufacturer for evaluation (scrapped).Note: manufacturer contacted customer in a follow-up call on (b)(6) 2023 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.
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Event Description
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Consumer reported complaint for the 32g trueplus pen needles.Consumer reported complaint for inaccurate dispense and aspiration and also stated that a few times the pen needles had bent when inserted into the skin.The package had not been open or damaged when received by the customer.The customer has been using the product for about 10 days.The customer is using compatible product and the pen needle is properly aligned.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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Sections with additional information as of 24-jul-2023: h6: updated fda¿s type, findings and conclusions codes.H10: customer had returned used pen needles, unable to be shipped to the manufacturer.Complaint was forwarded to supplier quality and internal evaluation was performed by the manufacturer using pen needles from the same lot.No abnormalities observed with retention samples.Most likely underlying root cause: mlc-009: use error caused or contributed to event.
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Search Alerts/Recalls
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