Catalog Number MZ9278 |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/15/2023 |
Event Type
malfunction
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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 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 maxzero¿ multi-fuse extension set with needleless connector tubing separated at the blue joint during use.The following information was provided by the initial reporter, translated from french: "tubing comes off very easily (at the blue joint between the manual clan and the junction of the 3 tubings).Seen before connection to the bb, therefore without consequence but could have been very serious.Event that already happened a short time ago in the department.Took another octopus and check before installation".
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Event Description
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It was reported that the bd maxzero¿ multi-fuse extension set with needleless connector tubing separated at the blue joint during use.The following information was provided by the initial reporter, translated from french: "tubing comes off very easily (at the blue joint between the manual clan and the junction of the 3 tubings) seen before connection to the bb, therefore without consequence but could have been very serious event that already happened a short time ago in the department took another octopus and check before installation".
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Manufacturer Narrative
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H6: investigation summary: a mz9278 sample was not available for investigation; however, the customer indicated the complaint sample was from lot 21099342.The feedback provided by the customer suggests the tubing disconnected prior to connection to the patient.As part of the feedback the customer provided a photograph; analysis of the photograph confirmed the customer's experience, as the back check valve component had broken in two, with part of it still solvent bonded to the tubing.The details of this feedback were forwarded to the manufacturing site for investigation.They confirmed that the root cause of the customer¿s experience could not be determined in this instance, as without a sample it is not possible to determine whether a manufacturing defect could have caused or contributed to the damaged component.A review of the production records for lot 21099342 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.
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Search Alerts/Recalls
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