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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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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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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The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 03-feb-2023.H6: investigation summary: 3 used samples for model # mp3503-c and lot # 22089413 were returned for investigation.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".Prior to functional testing the sets were visually examined for defects and abnormalities.No defects or abnormalities were observed.The sets were connected to a 10 ml bd syringe filled with water and attempted to be flushed.Two samples worked as intended, however one of the samples showed signs of occlusion at the female luer adapter connected to the maxplus connector.The sets were examined under a microscope and excess solvent was observed near the female luer which caused the backflow.The customer complaint could be replicated.Quality notification sent to manufacturer.A device history record review for model a device history record review for model mp5303-c and lot number 22089413 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.A trend for this occlusion issue has been identified for this product line.A capa (corrective action preventative action) has been initiated, and a team has been assembled in order to investigate the issue.
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Search Alerts/Recalls
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