Catalog Number MP5303-C |
Device Problem
Complete Blockage (1094)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/08/2022 |
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 maxplus¿ pressure rated extension set would not either flush or draw- felt like the line was occluded somehow, even though no visible blockage.The following information was provided by the initial reporter: customer had several mp5303-c extensions sets that would not either flush or draw- felt like the line was occluded somehow, even though no visible blockage.
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Manufacturer Narrative
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The following fields were updated due to additional information: b5: describe event or problem: it was reported that 3 bd maxplus¿ pressure rated extension set would not either flush or draw- felt like the line was occluded somehow, even though no visible blockage.The following information was provided by the initial reporter: customer had several mp5303-c extensions sets that would not either flush or draw- felt like the line was occluded somehow, even though no visible blockage.D10: device available for eval yes.D10: returned to manufacturer on: 20-jan-2023.H6: investigation summary: three used samples and 38 unused samples (model #mp5303-c) were returned by the customer.It was reported by customer that "extension sets would not flush or draw".The sets were examined for defects and abnormalities.No defects or abnormalities were observed.The set was connected to a 10ml bd syringe and attempted to be flushed with water.The sets were able to be flushed.The failure was unable to be replicated, and the complaint could not be verified.A root cause was unable to be determined because the failure was unable to be replicated.A device history record review for model mp5303-c lot number 22109064 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
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Event Description
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It was reported that 3 bd maxplus¿ pressure rated extension set would not either flush or draw- felt like the line was occluded somehow, even though no visible blockage.The following information was provided by the initial reporter: customer had several mp5303-c extensions sets that would not either flush or draw- felt like the line was occluded somehow, even though no visible blockage.
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Search Alerts/Recalls
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