Catalog Number 394602 |
Device Problems
Leak/Splash (1354); Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/17/2022 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that the bd connecta¿ 3-way stopcock was found damaged during use.The following information was provided by the initial reporter, translated from chinese: "the doctor used the infusion set to connect the connecta to flush the patient's right side of the pleural cavity.During the use, he found that after the connecta was closed, there was still fluid flowing freely.After the three-way tube was replaced immediately, the pleural cavity flushing went smoothly.This incident no adverse consequences to patients, but waste of materials and increased workload of doctors".
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Manufacturer Narrative
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H6: investigation summary: since no photos or samples displaying the reported condition of component damage - no leak were available for examination, we were unable to fully investigate this incident.The device history records (dhr) review was performed for the lot number material identified in this complaint.According to the documented records, the product was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.H3 other text : see h10.
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Event Description
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It was reported that the bd connecta¿ 3-way stopcock was found damaged during use.The following information was provided by the initial reporter, translated from chinese: "the doctor used the infusion set to connect the connecta to flush the patient's right side of the pleural cavity.During the use, he found that after the connecta was closed, there was still fluid flowing freely.After the three-way tube was replaced immediately, the pleural cavity flushing went smoothly.This incident no adverse consequences to patients, but waste of materials and increased workload of doctors".
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Search Alerts/Recalls
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