Catalog Number MP5301-C |
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 02/16/2023 |
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 maxplus¿ pressure rated extension set with needleless connector had a loose connection to the catheter and had to be reattached several times to securely lock it.The following information was provided by the initial reporter: "we are noticing also that with the connectors are not connecting to the catheter securely and it is taking multiple times of unattaching the catheter and reattaching the catheter to get them lock securely and not leak.".
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Event Description
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It was reported that the bd maxplus¿ pressure rated extension set with needleless connector had a loose connection to the catheter and had to be reattached several times to securely lock it.The following information was provided by the initial reporter: "we are noticing also that with the connectors are not connecting to the catheter securely and it is taking multiple times of unattaching the catheter and reattaching the catheter to get them lock securely and not leak.".
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Manufacturer Narrative
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H6: investigation summary: no product or photo was returned by the customer.It was reported by the customer "extension tubing would not flush with saline".The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review for model mp5301-c lot number 22109382 was performed.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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