Catalog Number 383734 |
Device Problems
Break (1069); Leak/Splash (1354); Split (2537)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/04/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device brand name: bd pegasus¿ safety closed iv catheter system (y luer with bd q-syte ¿ luer access split septum and end cap).Medical device expiration date: unknown.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 during use of the bd pegasus¿ safety closed iv catheter system (y luer with bd q-syte ¿ luer access split septum and end cap ¿on the first day of infusion the nurse found the e-tubing broken and leaking of normal saline.¿ there was no report of injury or medical intervention.
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Manufacturer Narrative
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Investigation summary: a sample was received for the purpose of our investigation.The investigators were able to observe the reported failure mode in the sample provided.The sample was observed under a microscope, it had residual ex-tubing in the pp adapter and the section of the ex-tubing was broken and is not flat and coarse.The batch record was reviewed, no related abnormalities were found.Investigation conclusion: it was found that a misalignment in the pegasus semi-auto process can crush and pull the tubing to create the reported failure mode.Although the root cause for this issue is related to the manufacturing process it should be noted that the rate of occurrence for this event is extremely low.
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Search Alerts/Recalls
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