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E1- customer (person): postal code: (b)(6).Phone: (b)(6).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.
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary it was reported that the "bung" has fallen off the end of a bakri tamponade balloon catheter.When it was stated that the "bung" had come off the end of the bakri tamponade balloon catheter, the customer was referring to the blue tap (stopcock) at the end of the bakri balloon.The device was placed transvaginally after a vaginally delivery for uterine tamponade.The amount of saline used to fill the balloon is unknown as the solution leaked when the stopcock came off the end of the balloon during installation.The customer noted that this was probably due to user error and not checking the port connection prior to instillation of saline.The customer believed they used it wrong and tried another device with the same outcome.Training for use of the device has been planned.It was reported that no adverse effects or additional procedures were required for the patient.Investigation ¿ evaluation a document-based investigation was performed including a review of complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions (mi), and quality control procedures of the device were conducted.The complaint device was not returned; therefore, no physical examinations could be performed.However, 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 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 the device history record for the complaint device could not be conducted nor could a search of other complaints associated with the complaint device lot number be completed, due to the lack of production lot information from the user facility.Review of the customer testimony and relevant manufacturing documents does not indicate that the device was manufactured out of specifications and does not suggest items in the lot or similar devices in the field or in house are nonconforming.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, no product returned, and the results of the investigation, the most probable cause of the reported 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.
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Date of event: an unspecified date in oct2023; d4 - lot #, expiration date.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.
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