|
Blank fields on this form indicate the information is unknown or unavailable.E1: customer (person) address = (b)(6); postal code = (b)(6) e3: customer occupation = unknown 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.
|
|
As reported, during a cesarean section, a cook bakri postpartum balloon with rapid instillation components was placed in the uterus transabdominally with 50ml of saline.The balloon leaked immediately.The device was not handled by or in the proximity of metal tools.Another device of the same type was used to complete the procedure.Prior to device placement the estimated blood loss was 1000ml.After the device placement the estimated blood loss was 500ml.The total estimated blood loss was 1500ml.The patient did not receive or require a blood transfusion.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention and did not experience any adverse effects due to this occurrence.
|
|
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation evaluation: as reported, during a cesarean section, a 'cook bakri postpartum balloon with rapid instillation components' was placed in the uterus transabdominally with 50ml of saline.The balloon leaked immediately.The device was not handled by or in the proximity of metal tools.Another device of the same type was used to complete the procedure.Prior to device placement the estimated blood loss was 1000ml.After the device placement the estimated blood loss was 500ml.The total estimated blood loss was 1500ml.The patient did not receive or require a blood transfusion.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention and did not experience any adverse effects due to this occurrence.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control (qc) procedures were conducted during the investigation.Visual inspection of the returned complaint device was also conducted.One, used, 'cook bakri postpartum balloon with rapid instillation components' was returned for investigation.Visual inspection noted that the balloon appears to be damaged or ruptured.Cook has concluded that the device was manufactured to specification.Additionally, 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 (dhr) found no related non-conformances reported for lot.A complaint history database search showed one other related complaints associated with the failure mode for the complaint device lot.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.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in the field.Cook also reviewed product labeling; the ifu [t_j-sosr_rev4; 'bakri postpartum balloon'] supplied with the device states the following in consideration of the reported failure mode: - "how supplied: upon removal from the package, inspect the product to ensure no damage has occurred." the complaint was confirmed based on customer testimony and evaluation of the returned device.Based upon the available information and results of the investigation, cook has concluded that the cause for the complaint could not be established.The appropriate personnel have been notified and cook will continue to monitor for similar events.Per the quality engineering risk assessment, 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.
|
