Catalog Number 383558 |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/12/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that while opening up a 1.75in bd nexiva¿ single-port with maxzero¿ needle-free connector, a 1.25in was inside the packaging instead.The following information was provided by the initial reporter: "good afternoon.Today it was reported to me that a customer went to open a 20g 1.75in nexiva and inside the packaging was a 1.25in nexiva.The packaged product ref # is (b)(4).The sample is available and was not used.Can you please send shipping material to me so that i may send it in to be examined?".
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Manufacturer Narrative
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H.6.Investigation: since a lot number could not be connected to the device identified in the complaint, bd investigators could not conduct a device history review for this event.Additionally, a sample has not yet been submitted for evaluation and testing, preventing bd engineers from conducting a full investigation and determining a root cause of the failure mode.
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Event Description
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It was reported that while opening up a 1.75in bd nexiva¿ single-port with maxzero¿ needle-free connector, a 1.25in was inside the packaging instead.The following information was provided by the initial reporter: "good afternoon.Today it was reported to me that a customer went to open a 20g 1.75in nexiva and inside the packaging was a 1.25in nexiva.The packaged product ref # is 383558.The sample is available and was not used.Can you please send shipping material to me so that i may send it in to be examined?".
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Search Alerts/Recalls
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