Device Problems
Labelling, Instructions for Use or Training Problem (1318); Device Markings/Labelling Problem (2911)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 09/20/2018 |
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.The device was not returned.
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Event Description
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It was reported that there have been a couple of incidents where a female length catheter from the tray was inserted into a male patient, allegedly due to unclear labelling on the box.The complainant alleged that the outside of the box of the bard tray was not clearly labeled.
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Event Description
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It was reported that there have been a couple of incidents where a female length catheter from the tray was inserted into a male patient, allegedly due to unclear labelling on the box.The complainant alleged that the outside of the box of the bard tray was not clearly labeled.
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Manufacturer Narrative
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The device was not returned for evaluation.The lot number is unknown therefore the device history record could not be reviewed.The product catalog number for this product is unknown.Therefore, bard is unable to determine the associated labeling to review.Although the product catalog number is unknown, this product ifus are found to be adequate based on past reviews.
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Search Alerts/Recalls
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