Catalog Number MP5303-C |
Device Problem
Backflow (1064)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/20/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluated by mfr: a device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported while using bd maxplus pressure rated extension set with removable needleless connector backflow occurred.There was no report of patient impact.The following information was provided by the initial reporter: the little blue part where the syringe is attached to flush the syringe is sticking and causing backflow of blood to come out.
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Manufacturer Narrative
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Investigation summary: no product or photo was returned by the customer for mat# mp3503-c , lot # 22089425.It was reported by customer that, "the little blue part where the syringe is attached to flush the syringe is sticking and causing backflow of blood to come out" could not be verified due to the product not being returned for failure investigation.A device history record review for model mp5303-c and lot number 22089425 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set of lot.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.
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Event Description
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It was reported while using bd maxplus pressure rated extension set with removable needleless connector backflow occurred.There was no report of patient impact.The following information was provided by the initial reporter: the little blue part where the syringe is attached to flush the syringe is sticking and causing backflow of blood to come out.
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Search Alerts/Recalls
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