Model Number R640914 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
Needle Stick/Puncture (2462)
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Event Date 07/09/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The sample was returned for evaluation.A follow-up report will be submitted once the investigation has been completed.
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Event Description
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During a breast biopsy when the radiologist remover the needle to extract the biopsy sample.The entire needle came out causing a needle stick to the radiologist.
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Event Description
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During a breast biopsy when the radiologist remover the needle to extract the biopsy sample the entire needle came out causing a needle stick to the radiologist.
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Manufacturer Narrative
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A review of one opened sample from the customer found the plunger was broken, confirming the complaint.The most probable cause for the broken plunger is due to excessive drying of the resin material used for hub molding which contributes to brittleness of the stylet plunger.As a corrective action, an automatic shutoff of the molding machine dryer has been implemented to prevent excessive drying of the resin material.The manufacture date of the lot affected in this complaint was prior to the corrective action implementation.
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Search Alerts/Recalls
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