Catalog Number 383539 |
Device Problem
Defective Device (2588)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/28/2019 |
Event Type
malfunction
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Manufacturer Narrative
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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 that bd nexiva¿ closed iv catheter system had a safety shield failure.This occurred on 2 separate occasions.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: material no: 383539, batch no: 9029871.It was reported that "there is resistance and almost a grinding sound wen separating the hub".Per description: feeling resistance and almost a grinding sound when separating the hub.It's almost as if there's a lack of lubricant on the needle piece that the hub slides over.Staff are hearing and feeling the issue when they are doing the first twist to break the seal before inserting into patient.
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Manufacturer Narrative
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H.6.Investigation summary: dhr review was performed on lot number 9029871; the lot number was built / packaged on nfa line 1 from 30jan 2019 thru 05feb 2019 for a quantity of (b)(4) units.Review of dhr revealed all required challenge samples, set-up and in process testing was performed in accordance with the quality plans.Two qns (200796262 (ip) and 200796279 (fg) both for difficult retraction) initiated on the build of this lot that might impact the outcome of the quality of the product relevant to the defect stated in the pir.Received two unused nexiva 18ga units.One unit was in an opened package and the other unit was loose and a package label from catalog number 383539, lot number 9029871.Visual/microscopic evaluation: the needles were not crimped, curved or bent.No cured adhesive was observed on the tip shields or the grips.There was witness marks observed on the retention washers.Simulation test: there was drag/grinding, and friction was felt during the retraction process.The disengagement on both units was tough.Needle o.D.Dimension: each needle was measured in three areas with the average measurement 0.0345¿ and 0.0347.(spec is 0.0348 +/- 0.0005).Disassembled the needle set to evaluate the retention washer: the retention washers were bent.Conclusion: manufacturing ¿ the defect needle disengagement difficult was identified and confirmed with both returned units.When there is no clearance between the top of the insertion finger pin and the bottom of the retention washer, the retention washer can be bent.The bent retention washer can cause the needle to drag/grind during retraction.
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Event Description
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It was reported that bd nexiva¿ closed iv catheter system had a safety shield failure.This occurred on 2 separate occasions.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: material no: 383539, batch no: 9029871.It was reported that "there is resistance and almost a grinding sound wen separating the hub" per description: feeling resistance and almost a grinding sound when separating the hub.It's almost as if there's a lack of lubricant on the needle piece that the hub slides over.Staff are hearing and feeling the issue when they are doing the first twist to break the seal before inserting into patient.
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Manufacturer Narrative
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The following fields have been updated with corrections: g.5.Pma/510(k)#: k183399.
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Event Description
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It was reported that bd nexiva¿ closed iv catheter system had a safety shield failure.This occurred on 2 separate occasions.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: material no: 383539 batch no: 9029871 it was reported that "there is resistance and almost a grinding sound wen separating the hub" per description: feeling resistance and almost a grinding sound when separating the hub.It's almost as if there's a lack of lubricant on the needle piece that the hub slides over.Staff are hearing and feeling the issue when they are doing the first twist to break the seal before inserting into patient.
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Search Alerts/Recalls
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