Model Number 175814 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
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Event Description
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An additional complaint was opened to document the excess silicone found on the tip of the catheter sample, that was received for a separate complaint.
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Manufacturer Narrative
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Received 1 used catheter with syringe and package labeling only.The reported event was confirmed as manufacturing related.During the visual inspection, a burr was noted at the catheter tip.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "visually inspect the product for any imperfections or surface deterioration prior to use." (b)(4).
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Event Description
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An additional complaint was opened to document the excess silicone found on the tip of the catheter sample, that was received for a separate complaint.
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Search Alerts/Recalls
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