Catalog Number 515573-ZAT |
Device Problem
Complete Blockage (1094)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/17/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation summary: the injector part of the actual product that was received was connected to a spike set, and when the liquid flow was confirmed, the liquid flowed out without any problems.In addition, when the actual luer lock connector part was connected to the mixed injection part upstream of the drip tube of the chemosafe infusion set, the liquid flowed without problems.The cause could not be identified because there was no abnormality such as clogging, and the event was not reproduced.This event is presumed to have occurred due to incomplete connection.In order to prevent the occurrence of poor fluid flow, as part of continuous quality improvement, we changed the shape of the terminal luer connector to the luer lock integrated type (fixed lock) so that the connection can be made more reliably.No anomaly was found on the dhr review.
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Event Description
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It was reported that the prm/n35/std/50cm was connected to the terumo infusion set, but saline wouldn't flow through it during use.The following information was provided by the initial reporter, translated from japanese to english: "connected to terumo infusion set.However saline didn't flow.Replaced by new product and it flowed.".
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Manufacturer Narrative
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Oem manufacturer: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.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 prm/n35/std/50cm was connected to the terumo infusion set, but saline wouldn't flow through it during use.The following information was provided by the initial reporter, translated from (b)(6) to english: "connected to terumo infusion set.However saline didn't flow.Replaced by new product and it flowed.".
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Search Alerts/Recalls
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