It was reported that while performing a mock insertion the nurse pre-tested the balloon and expressed that customer had been doing so because they found that some of the balloons did not disinflate.And on a couple of occasions, customer had to acquire a second tray.The balloon insertion did not simple until the entire water was discarded, and then when the syringe was empty, they were able to remove the 1 to 2 cc that had remained in the balloon.This happened a second time with a second folding in the same facility during this lca.Representative explained customer that they did not need to pretest the balloon when they were running into this issue and had a history of the balloon, not inflating across the hospital.Although they were able to remove the water after a few attempts, and once they had a completely empty syringe this was not reassuring for the customer.
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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.
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