Catalog Number 383512 |
Device Problem
Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/24/2024 |
Event Type
malfunction
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Event Description
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It was reported that bd nexiva single port luer connector cracked.The following information was provided by the initial reporter, translated from chinese to english: the head nurse reported that during the use of the product, the luer connector cracked after the indwelling needle was inserted for about 6 hours.The affected quantity is 2.Green claims are required, a complaint reply letter is required, and a complaint acceptance letter is required.Samples can be returned and photos can be provided.
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Manufacturer Narrative
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Reported address does not fit: (b)(6).H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
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Event Description
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No additional information.
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Manufacturer Narrative
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Investigation results: no photos or physical samples that display the reported condition were available for investigation.A device history record review was completed by our quality engineer team for provided material number 383512 and lot number 2306109.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.Based on the available information, an exact cause for this incident could not be identified.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
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Search Alerts/Recalls
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