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

Model Number G24237

Device Problem Material Puncture/Hole (1504)

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

Event Date 06/05/2020

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 tamponade treatment of post-partum hemorrhage using a cook bakri postpartum balloon with rapid instillation components, inflation of the balloon was not possible because there was a hole in the connection.Another bakri was used to complete the procedure.There were no adverse effects to the patient and the patient required no additional procedures as a result of this occurrence.

Manufacturer Narrative

Event summary: it is reported during tamponade treatment of post-partum hemorrhage using a cook bakri postpartum balloon with rapid instillation components, inflation of the balloon was not possible because there was a hole in the connection.Another bakri was used to complete the procedure.There were no adverse effects to the patient, and the patient required no additional procedures as a result of this occurrence.Investigation - evaluation: reviews of the complaint history, device history record, instructions for use (ifu), and quality control procedures of the device were conducted during the investigation.The device was not returned for investigation.Accordingly, a physical examination could not be performed.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 that nonconforming product exists in house or in the field.There were no identified gaps in the quality controls procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is packaged with instructions for use which states, "upon removal from the package, inspect the product to ensure no damage has occurred." based on the information available, investigation has concluded that a definitive cause could not be established for this event.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.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.

Event Description

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

• 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: 10211200
• MDR Text Key: 197913088
• Report Number: 1820334-2020-01218
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)220926(10)10039409
• 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
• Report Date: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2022
• Device Model Number: G24237
• Device Catalogue Number: J-SOSR-100500
• Device Lot Number: 10039409
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1