Catalog Number 385158 |
Device Problems
Complete Blockage (1094); Fitting Problem (2183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/15/2022 |
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 q-syte¿ tri-extension set luer connection was unable to connect to the posiflush syringe, resulting in the inability to prime along with having resistance in the septum.These events occurred 4 times each.The following information was provided by the initial reporter: "when the user is trying to prime the q syte tri extension 385158, not able to prime two lumens due to resistance in septum and not able to connect posiflush lue lok to q syte.".
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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval: yes.D10: returned to manufacturer on: 06-feb-2023.H6: investigation summary: our quality engineer inspected the 4 tri-extension sets returned with 12 q-syte samples submitted for evaluation.The reported issues of flow issues - fluid blockage and connection issues were confirmed upon inspection of the samples.Analysis of the samples showed that 6 of the q-sytes samples did not have the proper slit openings.Bd determined that the cause of the failure was associated to the manufacturing process.During the manufacturing process the septums of the q-sytes have a slit cut into them via a blade.If the blade is dull, broken, or missing in the manufacturing machinery than the slit will not be properly cut into the septum resulting in flow issues and leakage.Production records were reviewed, and this batch met our manufacturing specification requirements.
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Event Description
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It was reported that the bd q-syte¿ tri-extension set luer connection was unable to connect to the posiflush syringe, resulting in the inability to prime along with having resistance in the septum.These events occurred 4 times each.The following information was provided by the initial reporter: "when the user is trying to prime the q syte tri extension 385158, not able to prime two lumens due to resistance in septum and not able to connect posiflush lue lok to q syte.".
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Search Alerts/Recalls
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