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As reported, the cook bakri postpartum balloon with rapid instillation components leaked during treatment of a postpartum hemorrhage.After a cesarean section, the patient bled about 430ml.A cook bakri postpartum balloon with rapid instillation components was placed through the incision and 350ml of liquid was injected into the balloon and leakage was found.When the balloon was removed, only about 250ml of water was left in the balloon and the balloon was found to be leaking.Another bakri balloon was used to stop the bleeding successfully.The total blood loss was about 510ml the device was not handled by or in the proximity of any metal tools (i.E., forceps or suture needles) that may have damaged the balloon.No section of the device remained inside the patient's body.The patient did not require any additional procedures due to this occurrence.The complainant has not reported any adverse effects on the patient due to this occurrence.
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Blank fields on this form indicate the information is unknown or unavailable.H3: device has been returned and preliminary evaluation has been performed, however, our investigation is ongoing and device evaluation summary will be included in our follow up report once our investigation has been completed.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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Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Event description: as reported, the cook bakri postpartum balloon with rapid instillation components leaked during treatment of a postpartum hemorrhage.After a cesarean section, the patient bled about 430ml.A cook bakri postpartum balloon with rapid instillation components was placed through the incision and 350ml of liquid was injected into the balloon and leakage was found.When the balloon was removed, only about 250ml of water was left in the balloon and the balloon was found to be leaking.Another bakri balloon was used to stop the bleeding successfully.The total blood loss was about 510ml the device was not handled by or in the proximity of any metal tools (i.E., forceps or suture needles) that may have damaged the balloon.No section of the device remained inside the patient's body.The patient did not require any additional procedures due to this occurrence.The complainant has not reported any adverse effects on the patient 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, the instructions for use, and quality control procedures.One bakri tamponade balloon catheter was returned for investigation.Function testing noted a leak in the balloon material.A document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.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.Based on the available information, cook has concluded that the device was manufactured to specification and there is no evidence suggesting nonconforming product exists either 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.A review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.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." based on the information provided, inspection of the returned device, and the results of the investigation, a definitive cause of the event could not be determined.Per the quality engineering risk assessment, no further action is required.The appropriate personnel have been notified, and 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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