Device Problems
Misassembled (1398); Positioning Problem (3009)
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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 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 device was not returned.
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Event Description
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It was reported that the customer noticed when they pulled the magic 3 catheter package out of the box, the gripping sleeve and water were not properly placed in the bag.The catheter was upside down.They stated that it made it difficult to get the gripping sleeve to the top and it caused an inconvenience.They stated they would prefer if the gripping sleeve was onto the exit port.
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Event Description
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It was reported that the customer noticed when they pulled the magic 3 catheter package out of the box, the gripping sleeve and water were not properly placed in the bag.The catheter was upside down.They stated that it made it difficult to get the gripping sleeve to the top and it caused an inconvenience.They stated they would prefer if the gripping sleeve was onto the exit port.
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Manufacturer Narrative
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The device was not returned for evaluation.The lot number is unknown; therefore, a device history record could not be reviewed.Although the product code is unknown, the intermittent catheter labeling is found to be adequate based on past reviews.Correction: initial reporter name and address.
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Search Alerts/Recalls
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