MAUDE Adverse Event Report: COOK INC BAKRI TAMPONADE BALLOON CATHETER; OQY INTRAUTERINE BALLOON

Model Number G30673

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/27/2022

Event Type  malfunction  

Manufacturer Narrative

(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.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.

Event Description

As reported, a bakri tamponade balloon catheter, to treat postpartum hemorrhage, leaked from the three-way channel of the balloon catheter.The patient was admitted to the hospital at 10:33 on (b)(6) 2022 and delivered at 17:06.After delivery, the lower uterine segment contracted poorly, and bleeding was approximately 400 milliliters.The bakri tamponade balloon catheter was placed, and total blood loss was 450 milliliters two and a half hours after delivery.At 7:30 the next day, the patient was stable, and transferred back to the maternity ward.At 20:00 that evening, the patient's bed sheets were wet due to the bakri tamponade balloon catheter leaking water.Approximately 200 milliliters of water leaked and there was no obvious blood outflow from balloon catheter.The patient had good uterine contraction and no obvious vaginal bleeding.The patient was continuously observed, and the bakri tamponade balloon catheter was removed the next day with 20 milliliters of fluid left in the balloon.As reported, the process was "smooth" and there was no obvious vaginal bleeding.There have been no adverse effects reported due to the occurrence.

Manufacturer Narrative

Event summary: as reported, a bakri tamponade balloon catheter, to treat postpartum hemorrhage, leaked from the three-way channel of the balloon catheter.The patient was admitted to the hospital at 10:33 on (b)(6) 2022 and delivered at 17:06.After delivery, the lower uterine segment contracted poorly, and bleeding was approximately 400 milliliters.The bakri tamponade balloon catheter was placed, and total blood loss was 450 milliliters two and a half hours after delivery.At 7:30 the next day, the patient was stable, and transferred back to the maternity ward.At 20:00 that evening, the patient's bed sheets were wet due to the bakri tamponade balloon catheter leaking water.Approximately 200 milliliters of water leaked and there was no obvious blood outflow from balloon catheter.The patient had good uterine contraction and no obvious vaginal bleeding.The patient was continuously observed, and the bakri tamponade balloon catheter was removed the next day with 20 milliliters of fluid left in the balloon.As reported, the process was "smooth" and there was no obvious vaginal bleeding.There have been no adverse effects reported due to the occurrence.Investigation - evaluation.Reviews of the complaint history, device history record, instructions for use, and quality control procedures of the device were conducted during the investigation.No device was returned for investigation.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.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 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.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is provided with instructions for use which state, "upon removal from the package, inspect the product to ensure no damage has occurred." based on the available information, cook has concluded that the most probable cause for this 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.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: BAKRI TAMPONADE BALLOON CATHETER
• Type of Device: OQY INTRAUTERINE BALLOON
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 15690632
• MDR Text Key: 307090308
• Report Number: 1820334-2022-01660
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)240510(10)13950967
• Combination Product (y/n): N
• PMA/PMN Number: K170622
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G30673
• Device Catalogue Number: J-SOS-100500
• Device Lot Number: 13950967
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female