BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD Q-SYTE CLOSED LUER ACCESS DEVICE; SET, ADMINISTRATION, INTRAVASCULAR
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Catalog Number 385100 |
Device Problem
Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/15/2024 |
Event Type
malfunction
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Manufacturer Narrative
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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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It was reported that bd q-syte closed luer access device septum ruptured.The following information was provided by the initial reporter, translated from chinese to english: (b)(6) 2024 the nurse found that the connector was leaking when changing the liquid, and found that the upper soft silicone was ruptured after removing the liquid connector.
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Manufacturer Narrative
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Investigation results: no photographic evidence or physical samples were accessible to investigate the reported condition.Our quality engineer team conducted a comprehensive review of the device history record for the provided material number 385100 and lot number 3093407.This review did not uncover any abnormalities during the production process that could have caused this defect, and all quality tests were found to be within the specified standards.Unfortunately, the exact cause of this incident could not be determined based on the information available.We will continue to track and analyze complaints related to this device and the reported condition in order to identify any emerging trends.
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Event Description
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No additional information.
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Search Alerts/Recalls
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