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 only 3 way tsc catheter.The exterior of the sample was inspected and no evidence of a failure was found that would support the reported event.Per the functional testing, the balloon was inflated, using a lab syringe, with 10 cc water using normal fill technique and the balloon inflated without difficulty in 6 sec.The inflation funnel did not balloon out during inflation.The balloon was deflated and re-inflated again with quick fill technique and the balloon inflated without difficulty and the inflation funnel did not balloon out during inflation.The sample was dissected and did not find anything to contribute to the reported problem.The dimensional evaluation results were as follows: eye snip length: 3/32¿, eye snip width: 1/32¿, eye snip distance from distal cuff: 9/32¿, eye snip distance from proximal cuff: 6/32¿, rubberize thickness: 6 thou, reinforcement: 159 thou, inflation funnel thickness: 58 thou, balloon thickness (average): 23 thou, inflation lumen coverage: 8 thou.The reported event could not be confirmed as the problem could not be reproduced.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 inflate and deflate the balloon use a luer tip careless syringe".(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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