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It was reported that the two foley catheters were hard to remove which was placed in or on transplant patients.Then the catheter came out with some extra pain to the patients that small lip or bump the catheter had.Also stated that it was happened by two every year like before which was catheter kind of collapsed on itself.The trick was tried, but it was not helping the incidences.Per follow-up via email on (b)(6) 2020, the customer stated that there were 3 catheters were affected and used in 3 (male) patients.The three patients had experienced pain at the removal site.The two patients were receiving oral pain medication after removal and all the three patients had some hematuria that resolved quickly within the hour.Per follow-up information received on (b)(6) 2020, the customer stated that the patient was admitted for a kidney transplant.And 18 french foley was used and the nurse had removed the catheter with difficulty as it seemed to catch (or) sticky towards the end of the removal and the catheter had a lip/bump towards the tip which caused the catching to occur.After several attempts it was able to remove and the patient experienced discomfort during & immediately after removal, it was resolved.
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It was reported that the two foley catheters were hard to remove which was placed in or on transplant patients.Then the catheter came out with some extra pain to the patients that small lip or bump the catheter had.Also stated that it was happened by two every year like before which was catheter kind of collapsed on itself.The trick was tried, but it was not helping the incidences.Per follow-up via email on (b)(6) 2020, the customer stated that there were 3 catheters were affected and used in 3 (male) patients.The three patients had experienced pain at the removal site.The two patients were receiving oral pain medication after removal and all the three patients had some hematuria that resolved quickly within the hour.Per follow-up information received on 14dec2020, the customer stated that the patient was admitted for a kidney transplant.And 18 french foley was used and the nurse had removed the catheter with difficulty as it seemed to catch (or) sticky towards the end of the removal and the catheter had a lip/bump towards the tip which caused the catching to occur.After several attempts it was able to remove and the patient experienced discomfort during and immediately after removal, it was resolved.
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The reported event was confirmed manufacturing related.1 sample was confirmed to exhibit the reported failure.The device had not met specifications.The product was used for treatment.The product caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), used silicone foley.Visual evaluation of the returned sample noted one opened (without original packaging), used silicone foley.Visual inspection of the sample noted no obvious visible defects.The catheter balloon was inflated with 30 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and was difficult to inflate with less than 10 ml of solution advancing to the balloon.With the amount of solution that managed to get into the balloon, it was noted that the inflation notch notch appeared to be incompletely perforated.When the balloon was deflated, the inflation notch perforation was confirmed to be incomplete, which would also cause a failure to deflate or difficulty to remove.This does not meet the specification "notch not to penetrate drainage lumen and must be properly formed, inflation lumen no nicks allowed." a potential root cause for this failure could be ¿inadequate pressure on the machine to punch¿.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: ¿warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with applicable local, state, and federal laws and regulations.Warning: on catheter, do not use ointments or lubricants having petrolatum base.They will damage silicone and may cause the balloon to burst.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Unless package is opened or damaged.Caution: do not aspirate urine through drainage funnel wall.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Single use only.Do not reuse.Do not resterilize.For urological use only.Valve type: use luer slip tip syringe.Do not use needle.Recommended inflation capacities: 3cc balloon: use 5cc sterile water; 5cc balloon: use 10cc sterile water; 30cc balloon: use 35cc sterile water; do not exceed recommended capacities.Note: aggressive traction, particularly in the presence of suturing, is not recommended for silicone foley catheters.Bard, bardex and lubri-sil are registered trademarks of c.R.Bard, inc.Or an affiliate.U.S.Patent number (b)(4) and patent pending.To deflate catheter balloon: gently insert a luer slip tip syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.If you notice slow or no deflation, re-seat the syringe gently.Allow the balloon to deflate slowly on its own.Do not aspirate or manually accelerate the deflation of the balloon.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Visually inspect the product for any imperfections or surface deterioration prior to use." h11: section a through f - the information provided by bd 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 bd.H3 other text : the actual/suspected device was inspected.
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