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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Received 4 unopened and 1 opened silicone catheters.The opened sample was evaluated and a cuff roll was noted on the sample returned.The unopened catheters did not show any defects.All samples received were functionally evaluated.The results were as follows: sample #1: the balloon was inflated with air and deflated by itself.A cuff roll was not formed.After that, 10cc of a mix of water and blue methylene was introduced with a syringe and the catheter was left for 3 minutes resting on a flat surface.It was then deflated by itself and a cuff roll was not formed.Sample #2: the balloon was inflated with air and deflated by itself.A cuff roll was not formed.After that, 10cc of a mix of water and blue methylene was introduced with a syringe and the catheter was left for 3 minutes resting on a flat surface.It was then deflated by itself and a cuff roll was not formed.Sample #3: the balloon was inflated with air and deflated by itself.A cuff roll was formed.After that, 10cc of a mix of water and blue methylene was introduced with a syringe and the catheter was left for 3 minutes resting on a flat surface.It was then deflated by itself and a cuff roll was formed.Sample #4: the balloon was inflated with air and deflated by itself.A cuff roll was not formed.After that, 10cc of a mix of water and blue methylene was introduced with a syringe and the catheter was left for 3 minutes resting on a flat surface.It was then deflated by itself and a cuff roll was not formed.Sample #5: the balloon was inflated with air and deflated by itself.A cuff roll was formed.After that, 10cc of a mix of water and blue methylene was introduced with a syringe and the catheter was left for 3 minutes resting on a flat surface.It was then deflated by itself and a cuff roll was formed.Per the dimensional evaluation, the balloon active length of all samples were measured with a digital caliper.The results were as follows: sample #1: short side 0.5150¿ and on long side 0.5220¿ (specification is 0.5 - 0.8 in.).The balloon active length was found within specifications.Sample #2: short side 0.5255¿ and on long side 0.5325¿ (specification is 0.5 - 0.8 in.).The balloon active length was found within specifications.Sample #3: short side 0.5330¿ and on long side 0.5675¿ (specification is 0.5 - 0.8 in.).The balloon active length was found within specifications.Sample #4: short side 0.5265¿ and on long side 0.5280¿ (specification is 0.5 - 0.8 in.).The balloon active length was found within specifications.Sample #5: short side 0.5260¿ and on long side 0.5430¿ (specification is 0.5 - 0.8 in.).The balloon active length was found within specifications.The reported event was confirmed with an unknown cause on two of the samples received.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: "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.Allow the pressure within the balloon to force the plunger back and fill the syringe with water.If you notice slow or no deflation, re-seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If necessary, contact adequately trained professional for assistance, as directed by hospital protocol" (b)(4).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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