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

Catalog Number J-BUS-253000

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/02/2019

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.

Event Description

It is reported that while preparing for an unspecified procedure using a balloon uterine stent, the end user opened the package to inspect the device prior to use and found an unknown black stain on the balloon.This device was not used.No adverse events have been reported as a result of the alleged malfunction.

Manufacturer Narrative

Investigation ¿ evaluation a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, the device history record, drawings, instructions for use, quality control data, and trends.One unopened package was returned for investigation.The returned packaging confirms lot number 9060688.The visual exam of the returned device noted black particles on the balloon material, possibly black ink.A review of the device history records for lot 9060688 records found there were no non-conformances.A review of complaint history records revealed this complaint to be the only one associated with complaint lot number 9060688.The complaint was confirmed based on investigation of the returned device.The cause for this failure mode is a manufacturing issue.Appropriate manufacturing personnel have been informed of this event and completed retraining to prevent similar device failure in the future.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 has been no new information received since the last report was submitted.

• 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
• MDR Report Key: 8214403
• MDR Text Key: 132088262
• Report Number: 1820334-2019-00038
• Device Sequence Number: 1
• Product Code: KNA
• UDI-Device Identifier: 00827002170803
• UDI-Public: (01)00827002170803(17)210801(10)9060688
• Combination Product (y/n): N
• PMA/PMN Number: K952527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup
• Report Date: 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2021
• Device Catalogue Number: J-BUS-253000
• Device Lot Number: 9060688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2019
• Date Manufacturer Received: 02/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1