As reported, during treatment of a post-partum hemorrhage, a bakri tamponade balloon catheter leaked.Blood loss was approximately 600ml prior to use of the device.The device was placed with a sponge forceps and injected with 400ml saline.The user removed the device from the patient, and found a pinhole leak in the middle of the balloon.The device was replaced and hemostasis was achieved.The patient lost approximately 300ml of blood between device placement and achievement of hemostasis.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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Event description: as reported, during treatment of a post-partum hemorrhage, a bakri tamponade balloon catheter leaked.Blood loss was approximately 600ml prior to use of the device.The device was placed with a sponge forceps and injected with 400ml saline.The user removed the device from the patient and found a pinhole leak in the middle of the balloon.The device was replaced and hemostasis was achieved.The patient lost approximately 300ml of blood between device placement and achievement of hemostasis.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation ¿ evaluation.A visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record (dhr), specifications, the instructions for use (ifu), and quality control data.One bakri tamponade balloon catheter was returned for investigation.Inspection of the returned device noted: the catheter was returned in a used condition.The stopcock was attached to the inflation line.A functional test was performed by inflating the balloon with tap water.A leak was confirmed in the proximal end of the balloon material.Under magnification three grasper marks were observed on the balloon material.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.Because there were no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists 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.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: how supplied "upon removal from the package, inspect the product to ensure no damage has occurred." the puncture marks on the returned balloon were likely caused by sponge forceps during placement of the device.The most probable cause of the reported event was determined to be unintended user error.The risk analysis for this failure mode was reviewed, and it was determined that no additional risk mitigating activity is required.We will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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