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Blank fields on this form indicate the information is unknown or unavailable.H3: device evaluated by mfg = other (code unspecified, describe in h10) (81) = 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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As reported, following an emergency caesarean section delivery of twins due to hypertension, the patient experienced postpartum hemorrhage secondary to uterine atony.Prior to its use, the bakri tamponade balloon catheter was inspected and it inflated smoothly without any problems.The device was inserted transabdominally immediately after the delivery of the placenta.The balloon was filled with 30-40ml of saline before closing the hysterotomy, and an additional 150ml was added afterward.One day after device placement, the user aspirated the water to deflate the balloon and only 40ml of water was aspirated.The device was removed from the patient and the balloon was injected with water and found the balloon was leaking.The device was handled in the proximity of metal tools, such as forceps or suture needles, which may have damaged the balloon.The patient lost 400ml of blood before device use and an additional 44ml after the device failure.No interventions were performed before attempting device placement.Hemostasis was achieved with the device, 10 units of 'atonin' (uterotonic agent), and iodoform gauze.The patient received a transfusion of 2 units of red blood cells following a combined blood/amniotic fluid loss of 2360ml.No section of the device remained inside the patient's body.The patient did not require any additional procedures due to this occurrence.No additional patient consequences were reported.
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation evaluation.As reported, following an emergency caesarean section delivery of twins due to hypertension, the patient experienced postpartum hemorrhage secondary to uterine atony.Prior to its use, the bakri tamponade balloon catheter was inspected and it inflated smoothly without any problems.The device was inserted transabdominally immediately after the delivery of the placenta.The balloon was filled with 30-40ml of saline before closing the hysterotomy, and an additional 150ml was added afterward.One day after device placement, the user aspirated the water to deflate the balloon and only 40ml of water was aspirated.The device was removed from the patient and the balloon was injected with water and found the balloon was leaking.The device was handled in the proximity of metal tools, such as forceps or suture needles, which may have damaged the balloon.The patient lost 400ml of blood before device use and an additional 44ml after the device failure.No interventions were performed before attempting device placement.Hemostasis was achieved with the device, 10 units of 'atonin' (uterotonic agent), and iodoform gauze.The patient received a transfusion of 2 units of red blood cells following a combined blood/amniotic fluid loss of 2360ml.No section of the device remained inside the patient's body.The patient did not require any additional procedures due to this occurrence.No additional patient consequences were reported.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, 'bakri tamponade balloon catheter' was returned for investigation.Inspection noted that there was no glue on the distal side of the balloon.The investigation found that the affected component is supplied to cook from an external supplier.Cook requested that the supplier investigate this occurrence.The supplier reviewed manufacturing documentation of the complaint device, and could not determine a definitive root cause.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.Cook could not complete a review of the device history record (dhr) due to lack of lot information from the user facility.Cook could not complete a database search of other complaints associated with the complaint device lot number due to lack of lot information from the user facility.Review of the device history record, complaint history, quality control documents, and device failure analysis indicates that the device was not manufactured within specifications, but does not suggest items in the lot or similar devices in the field or in house are nonconforming.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." based on the information provided, inspection of the returned device, and the results of the investigation, cook has concluded a supplier manufacturing event likely contributed to this incident.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.
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