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

Model Number	G30673
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the "connector/pipe/tube" of a bakri tamponade balloon catheter was missing from the packaging during treatment of postpartum hemorrhage.The user noted that the connector/pipe/tube was missing while using the balloon.The procedure was completed with another like-device.The patient lost 1300cc of blood prior to device issue and an additional 500cc following device issue; total estimated blood loss was 1800cc.The patient received a blood transfusion of 2 units.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.However, the absence of the connector/pipe/tube caused a delay in treatment while another unspecified device packaging was opened.
Additional Manufacturer Narrative
E1: customer (person) postal code = (b)(6).E3: customer occupation = unknown.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 or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation.It was reported that the "connector/pipe/tube" of a bakri tamponade balloon catheter was missing from the packaging during treatment of postpartum hemorrhage.The user noted that the connector/pipe/tube was missing while using the balloon.The procedure was completed with another like-device.The patient lost 1300cc of blood prior to device issue and an additional 500cc following device issue; total estimated blood loss was 1800cc.The patient received a blood transfusion of 2 units.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.However, the absence of the connector/pipe/tube caused a delay in treatment while another unspecified device packaging was opened.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 device was returned for investigation in opened packaging.Contained in the packaging tray were a bakri balloon, adapter, and syringe.Because the returned device was complete, the investigation team assumed that the returned device was the complete device used to complete the procedure, rather than the incomplete complaint device.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.A review of the device history record (dhr) found no related non-conformances reported for this incident.A complaint history database search showed no other related complaints associated with the failure mode for the complaint device lot.While the device was not manufactured to current specifications, because there are 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 field.Cook also reviewed product labeling; the ifu 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." the complaint was confirmed based on customer testimony.Based upon the available information, inspection of the returned device, and results of the investigation, cook has concluded that the cause for the complaint was a manufacturing deficiency; employee awareness of the issue was conducted.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.

• Brand Name: BAKRI TAMPONADE BALLOON CATHETER
• Common Device Name: 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: 20494031
• Report Number: 1820334-2024-01370
• Device Sequence Number: 4106316
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)241220(10)14430619
• Combination Product (Y/N): N
• PMA/510(K) Number: K170622
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/20/2024
• Device Model Number: G30673
• Device Catalogue Number: J-SOS-100500
• Device Lot Number: 14430619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/07/2024
• Supplement Date Received by Manufacturer: 10/14/2024; 12/17/2024
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 11/12/2024; 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female