Catalog Number 515573-ZAT |
Device Problem
No Flow (2991)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/06/2019 |
Event Type
malfunction
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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.Date of event: unknown.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.Device manufacture date: unknown.
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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 as a side tube to flow saline through, but when attempting to run chemo through the spike set, it wouldn't flow through, resulting in the replacement of the prm/n35/std/50cm.The following information was provided by the initial reporter: "used terumo infusion set as a main route.Connected 515573-zat as a side tube and flowed saline.Connected with the spike set and hcp tried to flow chemo, however it didn't flow even pressed the bag of chemo.Replaced by new 515573-zat and the drug started to flow.".
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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 as a side tube to flow saline through, but when attempting to run chemo through the spike set, it wouldn't flow through, resulting in the replacement of the prm/n35/std/50cm.The following information was provided by the initial reporter: "used terumo infusion set as a main route.Connected 515573-zat as a side tube and flowed saline.Connected with the spike set and hcp tried to flow chemo, however it didn't flow even pressed the bag of chemo.Replaced by new 515573-zat and the drug started to flow.".
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Manufacturer Narrative
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Investigation: the injector part of the actual product we received was connected to the spike set (fa seal connector luer lock) and it was confirmed that the liquid flowed, but the liquid flowed out without problems.Based on the fact that there were no clogged abnormalities in the actual product and similar requests from multiple facilities, there was a possibility that something went wrong with the connection, so the following verification was carried out.1.The operation of connecting the actual lure lock connector to the mixed injection part on the upstream side of the drip cylinder of chemsafe infusion set was repeated 30 times, and the liquid was confirmed each time (confirmation of possibility of accidental fitting failure).As a result, no abnormality such as poor liquid flow was found in all operations.2.The operation of connecting the actual lure lock connector shallowly connected to the mixed injection part of the upstream part of the drip tube of chemsafe infusion set was repeated 10 times, and the liquid was confirmed each time (confirmation of the possibility of failure due to insufficient connection).As a result, no abnormality such as poor liquid flow was found in all operations.3.The actual lure lock connector received was connected to the mixed injection part of the upstream part of the drip cylinder of chemsafe infusion set, and liquid flow was checked for 24 hours.N = 3 (check for possible looseness and valve failure due to long-term connection).As a result, no abnormality such as poor liquid flow was found in all operations.Four.As a result of checking the shape and dimensions of the end of the luer lock connector for the unused product of the serial number for which the failure was proposed, no deviation of the specification range was recognized.Five.Serial numbers for which there was an offer for failure from multiple facilities the unused product of (1811212 c) and chemsafe infusion set were connected and liquid flow was confirmed.(reproducibility check, n = 20).As a result, no abnormality such as poor liquid flow was found in all operations. 6.Perform 200 operations each to connect the 2 types of luer lock connectors (lock part free structure and 1 type lock part) adopted by our company to the mixed injection part of the drip cylinder upstream part of chemosafe infusion set.The solution was confirmed (additional confirmation of the possibility of accidental fitting failure).As a result, no abnormality such as poor liquid flow was found in all operations.It was not possible to identify the cause because no abnormalities such as clogging were found in the results of surveying the returned actual product, and that the event of the offer could not be reproduced in the verification and confirmation as well.In addition, although there were multiple items other than this product that had n35 at the top and connected to the spike set, there were no similar offers.In order to prevent the occurrence of liquid flow defects, we will change the shape of the end luer connector to an integral luer lock (fixed lock) so that connection can be made more reliably as part of continuous quality improvement.
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Search Alerts/Recalls
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