The reported event was confirmed as manufacturing related.Evaluation found a pinhole on the sac collar which had caused water to leak out.The sample was examined under a microscope and it was identified that this is related to manufacturing.A potential root cause for this failure mode could be manufacturing related due to poor fill in latex during finish dipping.The device history record was reviewed and found a possible manufacturing issue(s) that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "1.Method for use: (1)do not reuse.(2)do not resterilize.(3)be careful that the catheter is not exposed to ointments, contrast medium or oil-based lubricants (including vegetable oils such as olive oil, mineral oils such as white petrolatum and animal oils).[they may damage the device and may burst balloon.] (4)do not hold the device with forceps, etc.Avoid contact with any blades or sharp-edged instruments.[catheter damage may cause balloon rupture and accidental balloon removal or failure to deflate or remove the balloon.]" h11:section a through f - the information provided by bd 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 bd.
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