MAUDE Adverse Event Report: COOK INC BALLOON UTERINE STENT; KNA INSTRUMENT, MANUAL, SPECIALIZED, OBSTETRIC-GYNECOLOGIC

Model Number G17562

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 11/01/2022

Event Type  malfunction  

Manufacturer Narrative

(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.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

As reported, prior to opening the packaging of a balloon uterine stent, foreign matter described as a "small bug" was noted in the packaging.A new device was used to complete the procedure.The device did not make contact with the patient.There have been no adverse effects to the patient reported.

Manufacturer Narrative

Event summary: as reported, prior to opening the packaging of a balloon uterine stent, foreign matter described as a "small bug" was noted in the packaging.A new device was used to complete the procedure.The device did not make contact with the patient.There have been no adverse effects to the patient reported.Investigation ¿ evaluation: reviews of the complaint history, device history record, instructions for use, and quality control procedures as well as a visual inspection of the device were conducted during the investigation.The device was returned in labelled unopened packaging for investigation.The foreign matter was found near the chevron seal and is approximately 2mm long, hard and brown in color.Under magnification it was not possible to identify what the source of foreign matter was.A document-based investigation evaluation was performed.No related non-conformances were recorded.No additional complaints were received for this product lot.The device history record review provides objective evidence that the device was manufactured to specification.Due to the individual nature of inspecting the finished packaged product, one non conforming product being found in the field does not indicate additional non conforming product in the field and at this time no other complaints have been reported for the lot.A review of relevant manufacturing documents was conducted.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The manufacturing contributed to the complaint.Based on the available information, cook has concluded the cause of this complaint is manufacturing related.Due to the small size of the piece of foreign matter its possible it was behind the label and not visible during final packaging inspection and then shifted during shipping.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per a review of risk documentation, 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: BALLOON UTERINE STENT
• Type of Device: KNA INSTRUMENT, MANUAL, SPECIALIZED, OBSTETRIC-GYNECOLOGIC
• 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: 15798954
• MDR Text Key: 307672586
• Report Number: 1820334-2022-01728
• Device Sequence Number: 1
• Product Code: KNA
• Combination Product (y/n): N
• PMA/PMN Number: K952527
• 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
• Report Date: 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2024
• Device Model Number: G17562
• Device Catalogue Number: J-BUS-404000
• Device Lot Number: 13843504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/09/2022
• Initial Date FDA Received: 11/15/2022
• Supplement Dates Manufacturer Received: 01/06/2023
• Supplement Dates FDA Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2021
• 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