Catalog Number MZ9277 |
Device Problems
Complete Blockage (1094); Leak/Splash (1354); Incomplete or Inadequate Connection (4037)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/15/2022 |
Event Type
malfunction
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Event Description
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It was reported that 1 bd maxzero¿ extension set was loose, leaked and was blocked.The following information was provided by the initial reporter : the user reported that the new maxzero extension tubing is causing many issues.They are having problems drawing blood out of this tubing with the iv start, it is very stiff and tight just pushing saline through this tubing and because they are so difficult to push anything through the tubing is popping off at the iv hub, which leaves an open iv and blood is then dripping out.
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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 1 bd maxzero¿ extension set was loose, leaked and was blocked.The following information was provided by the initial reporter : the user reported that the new maxzero extension tubing is causing many issues.They are having problems drawing blood out of this tubing with the iv start, it is very stiff and tight just pushing saline through this tubing and because they are so difficult to push anything through the tubing is popping off at the iv hub, which leaves an open iv and blood is then dripping out.
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Manufacturer Narrative
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H6: investigation summary: no product or photo was returned by the customer.The customer complaint of loose component-leak-flow issue - fluid blockage could not be verified due to the product not being returned for failure investigation.A device history record review for model mz9277 lot number 21116093 was performed.The search showed that a total of (b)(4) in 1 lot number was built on 09nov2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.
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Search Alerts/Recalls
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