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

Model Number G24237

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/29/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It is reported during treatment of a post-partum hemorrhage (pph) following a cesarean delivery using a cook bakri postpartum balloon with rapid instillation component, a leak was found in the balloon.A second bakri was used to achieve hemostasis.The patient did not experience any adverse effects as a result of this occurrence.Additional details regarding the patient and event have been requested.At this time, no additional information has been provided.

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.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 provided 17jul2020: blood loss was difficult to estimate.No quantities of blood loss before or after bakri placement could be provided.The user realized quickly that there was a leaked and changed the device immediately for a new one "which worked".The patient was covid-19 negative.

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 unchanged, unknown or unavailable.Additional information: d10, h6: method code.Investigation - evaluation.A visual inspection and functional testing of the returned device was conducted.The complainant returned one open package containing a bakri postpartum balloon catheter with rapid instillation components for investigation.Visual examination confirmed the catheter only was returned in used condition; rapid instillation components were not returned.Catheter received with the stopcock attached to the inflation line.A functional test was performed by inflating the balloon with tap water.A leak was confirmed in the proximal end of the balloon material causing immediate balloon deflation.Under magnification a cut was observed on the bottom end of the balloon material preventing balloon from maintaining inflation.Cook has concluded that the balloon was damaged by an instrument of undetermined origin.Unintended user error likely contributed to this incident.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

There is no new patient or event information to report.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable additional information: section c.Event description: as reported, following a cesarean procedure, postpartum hemorrhage occurred.After placement of the complaint device, inflation was attempted and a leak was observed.The device was removed, and another bakri balloon was used to successfully achieve hemostasis.No adverse effects were reported.Investigation evaluation: reviews of complaint history, device history record, quality control data, and the instructions for use(ifu) were conducted during the investigation.The device was not returned for investigation.Accordingly, no physical examinations could be performed.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 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 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) provided with the device state, "upon removal from the package, inspect the product to ensure no damage has occurred." cook could not determine a definitive cause of this event from the available information.The risk analysis for this failure mode was reviewed, and it was determined that no additional risk mitigating activity is required.We will continue our monitoring of similar complaints.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: 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
• MDR Report Key: 10244223
• MDR Text Key: 198330053
• Report Number: 1820334-2020-01267
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)221007(10)10065229
• Combination Product (y/n): N
• PMA/PMN Number: K170622
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2022
• Device Model Number: G24237
• Device Catalogue Number: J-SOSR-100500
• Device Lot Number: 10065229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Date Manufacturer Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 70