The reported event was confirmed.Visual evaluation of the returned sample noted one opened (without original packaging), 3-way temp sensing silicone foley catheter.Visual inspection of the sample noted that the thermistor wire was pulled from the tip.The tip of the wire descended within the thermistor lumen to the balloon area.Wire snaking was observed around bifurcation and funnel area.This is out of specification per the inspection procedure which states, "wire shall not be kinked, knotted or twisted." although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be, ¿catheter is stretched during insertion" 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.Caution: aggressive traction, particularly in the presence of suturing, is not recommended for 100% silicone balloon foley catheters.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.Note: compatible only with the bard criticore monitor, bard urotrack 224 monitor, and other 400-series temperature monitors.Interchangeability + 0.2oc at 37oc.Warning: this product should never be connected to the temperature monitor or connected to a cable during an mri procedure.Failure to follow this guideline may result in serious injury to the patient.It is important to closely follow these specific conditions that have been determined to permit the examination to be conducted safely.Any deviation may result in a serious injury to the patient.Caution: as with all temperature probes, in the presence of rf energy sources, local heating, temperature errors, and probe damage may occur.Do not stretch catheter.This will cause repositioning of probe.Do not use stylet.This will cause stretching of catheter.Distributed by: c.R.Bard, inc.Covington, ga 30014 u.S.A.1-800-526-4455 www.Bardmedical.Com manufactured in mexico bard, bardex, criticore and urotrack are registered trademarks of c.R.Bard, inc.Or an affiliate.Pk7602982 12/2006".
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