It was reported that the balloon on the foley catheter would not deflate.The complainant reported that the nursing staff tried flushing the balloon port, cutting the foley, and attempted to deflate the balloon with a spinal needle but was unsuccessful.The complainant noted that urology was then consulted and urojet was applied.Another attempt was made to deflate the balloon with the spinal needle when the foley slipped out on its own.The balloon and the catheter were reportedly intact.
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The reported event was confirmed manufacturing related since only the manufacturing site had access to the inflation notch.Visual evaluation of the returned sample noted one opened (without original packaging), used cut portion of a silicone foley.It was noted that this was the portion to be inserted into the patient and that the funnel end of the catheter was missing.Functional evaluation could not be performed by inflation and deflation due to sample condition.When the balloon was dissected, it was noted that the inflation notch was not present.Due to how nogales foley catheters are manufactured, the notch was out of specification since it prevented the product from functioning, but the proper specification could not be found due to the product number being unknown.The lot number is unknown; therefore, the device history record could not be reviewed.Although the product family is unknown, the urinary drainage product ifus are found to be adequate based on past reviews.
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It was reported that the balloon on the foley catheter would not deflate.The complainant reported that the nursing staff tried flushing the balloon port, cutting the foley, and attempted to deflate the balloon with a spinal needle but was unsuccessful.The complainant noted that urology was then consulted and urojet was applied.Another attempt was made to deflate the balloon with the spinal needle when the foley slipped out on its own.The balloon and the catheter were reportedly intact.
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