MAUDE Adverse Event Report: COOK INC COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS; OQY INTRAUTERINE BALLOON

Model Number G24237

Device Problem Inflation Problem (1310)

Patient Problems Hemorrhage/Bleeding (1888); Insufficient Information (4580)

Event Date 11/27/2021

Event Type  Injury  

Manufacturer Narrative

Occupation: coordinator.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

As reported, a cook bakri postpartum balloon with rapid instillation components was placed and would not inflate.There was a 2-way liquid return.Another same type device was used for the procedure.Additional information has been requested.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Event summary: as reported, a cook bakri postpartum balloon with rapid instillation components was placed and would not inflate.There was a 2-way liquid return.Another same type device was used for the procedure.Investigation - evaluation.A document-based investigation was performed including a review of complaint history, device history record, quality control data, and the instructions for use (ifu).The complaint device was not returned; therefore, no physical examinations could be performed.A review of the device history record found no non-conformances related to the reported failure mode.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 related complaints from the lot have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.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 warranted.Cook medical will continue to monitor this device via the complaints database 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.

Event Description

No new patient or event information since the last report was submitted.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: b1, b5, b7, h1, h6.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database 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.

Event Description

Additional information was received on 18apr2022: they noted the issues was detected in the lower third of the device during filling, but they could eventually use the product.The patient did not require additional procedure or prolonged hospitalization due to the occurrence.The balloon had been inflated with saline solution to 300cc.The specific time the device was placed after delivery is unknown, but it was noted that the delivery occurred at 1:00pm and the incident occurred at 4:55pm.The balloon was indwelling for one day.The nature of the hemorrhage was hypotonic-uterus.The medical staff had reviewed and noted clots and did a subsequent review of uterine atony.There was 850cc lost before device placement and 700cc lost after placement.This blood loss was quantified by cystoflo.No transfusions were necessary.

• Brand Name: COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS
• 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 ; 8128294891
• MDR Report Key: 13577886
• MDR Text Key: 290162217
• Report Number: 1820334-2022-00279
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)241012(10)14270718
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K170622
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G24237
• Device Catalogue Number: J-SOSR-100500
• Device Lot Number: 14270718
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2021
• 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 Age: 23 YR
• Patient Sex: Female