The reported event was confirmed as manufacturing related.The sample was evaluated and a pinhole was noted on the sac collar of the catheter that allowed water to leak out.The pinhole was examined under a microscope and was noted to be round and smooth.The exact cause of sample condition was confirmed as being related to the manufacturing process.A review of the manufacturing process indicated that the process was capable of producing the type of defect.The device history record was reviewed and found a possible issue(s) that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿(1) do not reuse.(2) do not resterilize.(3) this device contains 10% povidone-iodine, for patients with past history of allergic hypersensitivity to povidone-iodine or iodine, consider using alternative disinfectants.(4) 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.] (5) 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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