Catalog Number MZ1000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Insufficient Information (4580)
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Event Date 04/15/2021 |
Event Type
Injury
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that there was an infection while using maxzero needleless connector.The following information was provided by the initial reporter: customer gets in touch to request guidance on using the luer system device.Closed (bd max zero connector without needle) for the hospital's assistance teams.The patient safety center detected the occurrence of more serious events related to phlebitis in their service and in identifying causes, it observed considerable difficulty of the teams (they have many new professionals due to the pandemic context) in the use of the material in question.
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Event Description
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It was reported that there was an infection while using maxzero needleless connector.The following information was provided by the initial reporter: customer gets in touch to request guidance on using the luer system device.Closed (bd max zero connector without needle) for the hospital's assistance teams.The patient safety center detected the occurrence of more serious events related to phlebitis in their service and in identifying causes, it observed considerable difficulty of the teams (they have many new professionals due to the pandemic context) in the use of the material in question.
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Manufacturer Narrative
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H.6.Investigation: an mz1000 sample was not available for investigation of this feedback; however the customer indicates that the health care practitioners experienced issues with using the maxzero device which resulted in an increase in occurrence of phlebitis.A review of the production records for lot 20085529 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The root cause of the customer¿s experience could not be determined in this instance.Without a sample or additional information regarding the details of the nature of the feedback it is not possible to determine whether a manufacturing defect could have caused or contributed to the reported issue.
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Search Alerts/Recalls
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