|
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.
|
|
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Event description: as reported, a cook bakri postpartum balloon with rapid instillation components was used to treat postpartum hemorrhage after a normal spontaneous delivery.The balloon was unable to be inflated by the syringe.The estimated blood loss prior to the difficulty was 200 to 300 cc.After the difficulty the patient lost 500 cc of blood.The total estimated blood loss was 600 cc.Another bakri provided syringe was used to complete the procedure.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.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 (dhr), the instructions for use (ifu), and quality control procedures.The complaint device was returned for evaluation.Liquid was observed in the syringe.The liquid was difficult to expel, and the syringe was unable to be drawn back.The tip of the syringe appeared to have glue or residue of some kind blocking the hole.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.Because there were no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists 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.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." the most probable cause of the reported event could not be determined from the available information.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.
|
