The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard 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 bard.
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The reported issue (it was reported that the water from the balloon was yellow and looked like urine when using a syringe to remove the catheter) was confirmed.The sample was returned and the visual evaluation did not observe a cuff roll.However, there appeared to be a ridge/cuff on the balloon, which was confirmed during the preliminary evaluation made by the field assurance team (visual inspection noted there appeared to be a ridge/cuff on the balloon).During the functional evaluation the cuff roll did not formed.The dimensional evaluation of the catheter was found to be within specification.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: ¿ caution: do not aspirate urine through drainage funnel wall.Note: aggressive traction, particularly in the presence of suturing, is not recommended for 100% silicone foley catheters.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.To deflate catheter balloon: gently insert a 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." the information provided by bard 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 bard.
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