Catalog Number 0165L14 |
Device Problems
Incorrect Measurement (1383); Inadequacy of Device Shape and/or Size (1583)
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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 tubing was shorter than normal and pulled the catheter down.
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Manufacturer Narrative
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This report is being submitted past the regulatory timeframe.Please see attached letter for additional information.The device was not returned for evaluation.However, the potential root cause for this failure mode could be wrong product size selected/speed controller faulty/mix product (catheter).The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "visually inspect the product for any imperfections or surface deterioration prior to use.Use luer tip syringe to inflate with stated ml of sterile water.Or for pre-filled products, remove clips and squeeze reservoir to inflate with stated ml of sterile water.".
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Event Description
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It was reported that the tubing was shorter than normal and pulled the catheter down.
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Search Alerts/Recalls
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