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

Model Number N/A

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/17/2023

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.E1: customer (person) phone = (b)(6).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 Description

As reported, the stopcock of a 'cook bakri postpartum balloon with rapid instillation components' was missing upon opening of the package.The patient had a vaginal delivery followed by postpartum hemorrhaging.The device packaging was opened and it was noted that the 3-way connector stopcock valve was missing.The procedure was completed using another 'cook bakri postpartum balloon with rapid instillation components' device for tamponade.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation ¿ evaluation: as reported, a patient's delivery was complicated by severe hemorrhage, requiring the use of a bakri balloon.When the packaging for the 'cook bakri postpartum balloon with rapid instillation components' was opened, the three-way connector was observed to be missing.Another new device was used to successfully achieve hemostasis.No adverse effects were reported.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures, as well as a visual inspection of the returned device, were conducted during the investigation.The complaint device was returned for evaluation.The dual check valve was missing from the opened package.Additionally, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also completed a review of the dhr.The dhr for the complaint lot recorded no related nonconformances to the reported incident.A database search for complaints on the reported lot found no additional complaints reported from the field.Review of the device history record, complaint history, and quality control documents indicates that the device was not manufactured within specifications, but does not suggest items in the lot or similar devices in the field or in house are nonconforming.Cook also reviewed product labeling.The product ifu, t_j-sosr_rev2 ¿bakri postpartum balloon,¿ 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." based on the information provided, inspection of the returned device, and the results of the investigation, cook has concluded a manufacturing and quality control deficiency contributed to the reported failure.Defect awareness training was issued for the personnel responsible for the manufacturing of an out of specification device.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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: 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 ; 8123392235
• MDR Report Key: 18138765
• MDR Text Key: 328125110
• Report Number: 1820334-2023-01570
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)250127(10)14501363
• Combination Product (y/n): N
• PMA/PMN Number: K170622
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: J-SOSR-100500
• Device Lot Number: 14501363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2022
• 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 Sex: Female