Catalog Number MZ5303 |
Device Problems
Loose or Intermittent Connection (1371); Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/22/2024 |
Event Type
malfunction
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Manufacturer Narrative
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E1: initial reporter facility name (b)(6) medical university hospital h.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
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Event Description
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It was reported that bd maxzero multi-fuse pressure rated extension set with needleless connector( was loose the following information was received by the initial reporter with the following: it was reported that loose connections when an external extension tube is connected/used on the ward to an mz5303 that has returned to the ward while connected to an indwelling needle in the operating theatre.
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Manufacturer Narrative
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Investigation results: one mz5303 sample was received for investigation without packaging, with some residual fluid present in the tubing; the sample was received connected to an unknown catheter.No sample of the products used to access the mz5303 were provided to aid the investigation.The customer reported that the connection between the maxzero and an unknown extension set appeared loose.Further information provided by the customer indicates that no leakage, and no disconnection occurred as a result of the loose connection.A visual inspection of the returned samples did not identify any product defects or manufacturing issues which could have caused or contributed to the customer's experience.Functional testing confirmed the connection between the maxzero and other bd stock product remained secure when connected; no inadvertent disconnection occurred throughout testing despite various attempts at manipulation.The details of this feedback were forwarded to the manufacturing site for investigation.In this instance, a definitive root cause could not be identified as testing of the returned sample did not identify any product defects that could have contributed to the customer¿s experience.A lot number was not provided as part of the investigation; however a review of the laser id 232244a06 from the maxzero component confirmed a possible lot number to be either 23089348 or 23089350.A review of the production records for potential lot numbers did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.Although it was not possible to determine a definitive root cause for the customers experience, the quality team at the manufacturing site has been informed of this complaint in order to be aware of the reported failure mode during future production of this product.
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Event Description
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No additional information.
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Search Alerts/Recalls
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