Catalog Number MX9433 |
Device Problem
Component Missing (2306)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/27/2023 |
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 maxguard¿ administration set with needleless y-site had no end on the tubing to connect it to the iv.The following information was provided by the initial reporter: "d iv tubing was flawed.On opening iv tubing it was noted that there was no end on the tubing to connect it to the iv start tubing that would be used on the pt.New tubing set was obtained to attach to iv bag.Pt not aware that there was any issue with the iv tubing and not involved because it was discovered before the iv was started.Was there only one occurrence of this issue? yes.So far we have only heard of it happening once.Was there any patient harm or adverse or adverse events? no patient harm.Issue was discovered before it ever reached a patient.".
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Event Description
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It was reported that the bd maxguard¿ administration set with needleless y-site had no end on the tubing to connect it to the iv.The following information was provided by the initial reporter: "d iv tubing was flawed.On opening iv tubing it was noted that there was no end on the tubing to connect it to the iv start tubing that would be used on the pt.New tubing set was obtained to attach to iv bag.Pt not aware that there was any issue with the iv tubing and not involved because it was discovered before the iv was started.Was there only one occurrence of this issue? yes ¿ so far we have only heard of it happening once.Was there any patient harm or adverse or adverse events? no patient harm.Issue was discovered before it ever reached a patient.".
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Manufacturer Narrative
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Investigation summary: one sample was received for quality investigation.The customer complaint of misassembly was verified by visual inspection.Evaluation of the sample submitted shows that the distal connection of the extension set is missing from the assembly.A device history record review for model mx9433 lot number 22129074 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for the missing connection is a failure at the manufacturing facility to construct the assembly correctly.The manufacturing location has conducted an investigation into the issue and it was determined that the root cause for the issue was due to the technician not assembling the infusion set correctly.
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Search Alerts/Recalls
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