Catalog Number MP5314C-BNS |
Device Problem
Component Missing (2306)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/31/2023 |
Event Type
malfunction
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Event Description
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It was reported by customer that " 79 bd maxplus¿ extension set are missing connectors from one end." the following information was provided by the initial reporter: bd maxplus¿ extension set are missing connectors needleless connector extension set missing connectors from one end, lot 21129130.
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Manufacturer Narrative
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Device expiration date: na.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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Manufacturer Narrative
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H6: investigation summary: a complaint of sets missing connector was received from the customer.30 samples were returned for investigation.Through comparison with the assembly drawing, the customer complaint of misassemble was confirmed.All samples were missing the nac plus component.A device history record review for model mp5314c-bns lot number 21129130 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.To define the root cause, an audit was carried out in the production line with a similar model where accumulated material was observed due to the rest time.At the end of the rest time, the nac component is placed on all the sets, and the flow test is carried out.Therefore, the accumulation can cause confusion between the material with nac and without nac and pass incorrectly assembled sets directly to sealing.A quality alert was issued to all involved personnel to prevent this defect in the future.
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Event Description
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It was reported by customer that " 79 bd maxplus¿ extension set are missing connectors from one end." the following information was provided by the initial reporter: bd maxplus¿ extension set are missing connectors needleless connector extension set missing connectors from one end, lot 21129130.
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Search Alerts/Recalls
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