Catalog Number 383312 |
Device Problem
Bent (1059)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/11/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that the nurse found a needle bent after opening needle cover of bd saf-t-intima¿ iv catheter safety system.Found before use.No reports of serious injury or medical intervention noted.
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Manufacturer Narrative
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Correction: the bent needle indicated in the event description is not a reportable event malfunction, and this incident was over reported.
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Manufacturer Narrative
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Investigation summary: bd received a sample and a picture for investigation.The reported defect was confirmed in defective sample and picture received.However, based on the received sample and picture, we cannot confirm or associate the defect to manufacturing process.Currently we have adequate controls to detect cosmetic defect during loading of the material in the tray and after packaged.Based on dhr review for lot reported catalog 383312, all samples taken for visual and functional characteristics properly met the acceptance criteria.Investigation conclusion: based on investigation results to date, root cause for needle bent cannot be determined to manufacturing process.
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Search Alerts/Recalls
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