|
Blank fields on this form indicate the information is unknown or unavailable.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 or that a death or serious injury occurred; nor is it admission 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, while testing prior to placement, a cook bakri postpartum balloon with rapid instillation components' balloon leaked from a pinhole.The device did not make any patient contact.The procedure was completed using a new device.The device was not handled by or in the proximity of any metal tools and the patient did not receive any blood transfusions.A section of the device did not remain inside the patient¿s body.The patient did not require any other additional intervention or experience any adverse effects due to this occurrence.
|
|
Event summary as reported, while testing prior to placement, a cook bakri postpartum balloon with rapid instillation components' balloon leaked from a pinhole.The device did not make any patient contact.The procedure was completed using a new device.The device was not handled by or in the proximity of any metal tools and the patient did not receive any blood transfusions.A section of the device did not remain inside the patient¿s body.The patient did not require any other additional intervention or experience any adverse effects due to this occurrence.Investigation ¿ evaluation a document based investigation was performed including a review of complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures, as well as a visual inspection and functional test of the device, were conducted.The device was returned to cook for investigation.The device was function tested by inflating with water, and leakage was observed from the balloon material.Visual examination noted a cut in the balloon material at the leakage site.A document-based investigation evaluation was performed.No related non-conformances were recorded.No additional complaints were received for this product lot.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 and quality control documents was conducted.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also reviewed product labeling.The product ifu, t_j-sosr_rev4 ¿bakri postpartum balloon,¿ 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 available information, inspection of the returned device, and results of the investigation, cook concluded a definitive cause of the event could not be determined.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.
|
