MAUDE Adverse Event Report: COOK UROLOGICAL INC BAKRI TAMPONADE BALLOON CATHETER; KNA INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC

Catalog Number J-SOS-100500

Device Problems Hole In Material (1293); Leak/Splash (1354)

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

Event Date 02/12/2015

Event Type  malfunction  

Manufacturer Narrative

This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.

Event Description

During the procedure, it was reported a balloon leakage was noted.As a pin hole was found while injecting saline.The user then changed to another one.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: BAKRI TAMPONADE BALLOON CATHETER
• Type of Device: KNA INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC
• Manufacturer (Section D): COOK UROLOGICAL INC; 1100 west morgan st; spencer IN 47460
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 7213285
• MDR Text Key: 98289071
• Report Number: 1820334-2018-00242
• Device Sequence Number: 1
• Product Code: KNA
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)161101(10)U2431345
• Combination Product (y/n): N
• Reporter Country Code: CN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: J-SOS-100500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• 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