Catalog Number 394900 |
Device Problems
Leak/Splash (1354); Air/Gas in Device (4062)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/21/2022 |
Event Type
malfunction
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Event Description
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It was reported that 2 bd connecta¿ plus stopcocks had air in the line and leaked fluid from between the connector and extension tubing during use.The following information was provided by the initial reporter, translated from japanese: "the customer reported about leakage of the fluid and air coming from the connection between the connector (cat#: 394900) and top corporation's ext.Tubing.Another product was used to complete the administration.".
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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 2 bd connecta¿ plus stopcocks had air in the line and leaked fluid from between the connector and extension tubing during use.The following information was provided by the initial reporter, translated from japanese: "the customer reported about leakage of the fluid and air coming from the connection between the connector (cat #: 394900) and top corporation's ext.Tubing.Another product was used to complete the administration.".
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Manufacturer Narrative
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H6.Investigation summary: our quality engineer inspected the 1 sample submitted for evaluation.The reported issues of leakage and air bubbles / air in line were not confirmed upon inspection and testing of the samples.Analysis of the sample showed that there were no abnormalities or defects on the returned sample.The returned sample underwent our internal leakage testing, and the sample showed no signs of leakage.Since the failure modes were not confirmed during sample evaluation a manufacturing related root cause could not be determined.Production records were reviewed, and this batch met our manufacturing product specification requirements.
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Search Alerts/Recalls
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