Model Number 1758SI16 |
Device Problems
Nonstandard Device (1420); Material Integrity Problem (2978)
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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 foley catheter was stiffer than usual, which prevented it from fitting well within the statlock.The complainant alleged that the urine would not drain until the catheter was taken out of the statlock device.
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Manufacturer Narrative
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The device was not returned for evaluation.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: ¿perform hand hygiene immediately before and after insertion insert urinary catheters using aseptic technique and sterile equipment use the smallest foley catheter possible, consistent with good drainage document the indications for catheter insertion, date and time of catheter insertion, individual who inserted catheter, and date and time of catheter removal in the patient record".
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Event Description
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It was reported that the foley catheter was stiffer than usual, which prevented it from fitting well within the statlock.The complainant alleged that the urine would not drain until the catheter was taken out of the statlock device.
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Search Alerts/Recalls
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