This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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As reported, during treatment of a post-partum hemorrhage, a bakri tamponade balloon catheter leaked from a pinhole in the balloon.The leak was discovered during testing of the device.The device did not make patient contact.A new device was used to achieve hemostasis without any adverse effect to the patient.
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary: as reported, during treatment of a post-partum hemorrhage, a bakri tamponade balloon catheter leaked from a pinhole in the balloon.The leak was discovered during testing of the device.The device did not make patient contact.A new device was used to achieve hemostasis without any adverse effect to the patient.Investigation - evaluation: reviews of the complaint history, device history record, instructions for use, and quality control procedures and a visual inspection and functional test of the device were conducted during the investigation.The device was returned for investigation.Visual examination did not observe any damage to the balloon.A function test was performed by inflating the device with water.No leaks were observed.A review of complaint history records shows one other related complaint associated with the complaint device lot, reported under manufacturer report #1820334-2022-01267.Due to the individual nature of the manufacturing and inspection process for the devices in the lots, it is unlikely that these events are an indication of device issue within the entire lot.No nonconformances were recorded for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is provided with instructions for use which state, "upon removal from the package, inspect the product to ensure no damage has occurred." based on the available information, cook has concluded that the complaint was not confirmed, as the returned device functioned as intended.Evaluation of the returned device could not re-create the failure mode.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per a review of risk documentation, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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