BARD ACCESS SYSTEMS GROSHONG NXT WITH STRIPED CATH 4F SINGLE LUMEN BASIG JAPAN HANG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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Model Number N/A |
Device Problem
No Flow (2991)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/29/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
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Event Description
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It was reported that although the preflashing was performed without problems before catheter insertion, the blood return was not confirmed after the catheter placement.When priming the catheter, saline solution could not be infused.It was stated the operator suspects that the catheter's three way valve is not working properly.There was no patient injury reported.
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Manufacturer Narrative
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The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of an occluded catheter was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 4fr groshong catheter.The sample was received assembled.Light usage residues were observed.The catheter appeared bunched and kinked beneath the clear strain-relief sleeve.Microscopic inspection of the sample confirmed bunching of the catheter beneath the strain relief sleeve.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be fully occluded.The bunched region of catheter was straightened by pulling gently on the catheter shaft.Patency was established following straightening of the catheter.The observed catheter occlusion was caused by the bunching and kinking of the catheter beneath the strain-relief sleeve.That bunching appeared to have been caused by compressing the catheter during connector assembly.The product ifu provides instructions for proper catheter/connector system assembly.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
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Event Description
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It was reported that although the preflashing was performed without problems before catheter insertion, the blood return was not confirmed after the catheter placement.When priming the catheter, saline solution could not be infused.It was stated the operator suspects that the catheter's three way valve is not working properly.There was no patient injury reported.
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