Model Number PNDL, 5BV TVH TP 31G 5MM100CT 30/CS |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/12/2023 |
Event Type
malfunction
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Event Description
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Consumer reported complaint for the trueplus pen needles.Wife is calling on behalf of the customer.Customer stated that when the protective cover from the 31g pen needles is removed, the needles are bent.Customer did not disclose how long he has been using the 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 properly aligned.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).Customer had returned two used pen needles without the protective cover - unable to be shipped to manufacturer due to needle exposed.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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Manufacturer Narrative
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Sections with additional information as of 24-jul-2023: customer had returned two used pen needles without the protective cover - unable to be shipped to manufacturer due to needle exposed.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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