H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one presto inflation device was returned for evaluation connected to a boston scientific athletis balloon.Unknown liquid was noted in the device.The unknown liquid was flushed from the presto device.The presto device was then filled with water and an attempt was made to inflate the balloon.Water was noted leaking at the 3-way stopcock.Under microscopic observation, a crack was noted at the 3-way stopcock.The 3-way stopcock was removed from the presto device.The presto device was then connected to an in-house pressure gauge, the piston handle was turned to read 8 atm and 12 atm.The psi reading on the pressure gauge remained at 0.No other functional testing was performed.Therefore, the investigation is confirmed for the reported inflation issue as water was noted leaking from a crack at the 3-way stopcock during inflation, and after the cracked stopcock was replaced, the psi reading remained at zero when the atm was increased.Thus, the investigation is also confirmed for the identified crack on stopcock and incorrect pressure gauge reading.A definitive root cause for the alleged inflation issue, identified crack on stopcock and incorrect pressure gauge reading could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 10/2025).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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