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

Model Number G24237

Device Problem Break (1069)

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

Event Date 02/04/2020

Event Type  malfunction  

Manufacturer Narrative

Pma/510k #: k170622.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported that during a bakri balloon insertion for management of a postpartum hemorrhage due to cervical laceration and uterine atony, the syringe of the cook bakri postpartum balloon with rapid instillation components broke off in the hub preventing inflation.Around four hours after delivery, the patient had lost 2500 ml of blood and the first cook bakri balloon was placed transvaginally.After it was placed the balloon was being filled with saline when the syringe broke off within the stopcock.Another bakri balloon was used to achieve hemostasis.The patient received four units of prbc after losing 1500 ml of blood.No adverse effects related to the alleged malfunction were reported.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.H6: ec method code desc - 5: communication/interviews (4111).Investigation ¿ evaluation.Cook was informed on (b)(6) 2020 of an incident involving a cook bakri postpartum balloon with rapid instillation components.As reported, the needle broke off in the hub of the complaint device during management of postpartum hemorrhage.Hemostasis was achieved using another bakri balloon device.No adverse effects were reported as a result of this issue.A visual inspection of the returned device was conducted.A document-based investigation was also performed including a review of complaint history, device history record, the instructions for use, drawing, documentation and specifications.Visual examination confirmed the a dcv-100020 dual check valve only was returned in used condition.The balloon catheter and rapid instillation component were not returned.The bottom side of the check valve was occluded with plastic like material.The plastic was lodged inside the fitting and could not be removed.A review of the device history record (dhr) 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 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.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." a review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Cook has concluded unintended user error 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

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

• 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: 9677782
• MDR Text Key: 178142034
• Report Number: 1820334-2020-00300
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)221120(10)10162713
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2022
• Device Model Number: G24237
• Device Catalogue Number: J-SOSR-100500
• Device Lot Number: 10162713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Date Manufacturer Received: 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 77