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

Model Number J-SOSR-100500

Device Problems Component Missing (2306); Packaging Problem (3007)

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

Event Date 09/27/2016

Event Type  malfunction  

Event Description

Bakri balloon is missing port on the stopcock that allows it to be a closed system.Bakri was used and filled with syringe so no delay in patient care, however, the box is labeled differently than what is inside.

• Brand Name: BAKRI TAMPONADE BALLOON CATHETER
• Type of Device: INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC
• Manufacturer (Section D): COOK INC.; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6046677
• MDR Text Key: 58066931
• Report Number: 6046677
• Device Sequence Number: 1
• Product Code: KNA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 07/05/2019
• Device Model Number: J-SOSR-100500
• Device Catalogue Number: G24237
• Device Lot Number: 7094229
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2016
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25 YR