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

Catalog Number J-SOS-100500

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

It was reported post cesarean section procedure, the physician placed the balloon transabdominally and then finished the suturing.The patient had lost 400 ml of blood at the time before placing the bakri tamponade balloon catheter.In addition, the patient was injected with oxytocin before using the bakri balloon to stop the bleeding.As explained, the physician used the enclosed syringe to fill the balloon but found the liquid flowed out slowly along the drainage tube.Finally, the saline injected reached to 300ml.The next day the physician withdrew the balloon and found only 30ml remained in the balloon.The physician cleaned the balloon and injected the water 300ml to observe.The leakage was found during the process of injecting.However, on the third day the balloon had no leak and was still within 300ml of water.No unintended portion of the device remained inside the patient¿s body.No additional procedures were required due to this occurrence.No adverse effects or consequences were reported to the patient due to this occurrence.

Manufacturer Narrative

Investigation ¿ evaluation: visual inspection and functional testing of the returned device was conducted.The investigation also included review of complaint history, the device history record, drawings, quality control data, and specifications.One device was returned for investigation.A functional test was performed to check for leaks.The balloon does not leak; the stopcock does not leak.The balloon was leak tested 2 times and no leaks or lumen communication could be located.The difficulty the customer experienced with the complaint device could not be recreated in the lab.A review of the device history record found no non-conformances associated with the complaint device lot number (8131930).A review of complaint history revealed there has been no other complaint associated with the complaint device lot number (8131930).Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.The root cause of this reported event is undeterminable.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: BAKRI TAMPONADE BALLOON CATHETER
• Type of Device: KNA INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7177886
• MDR Text Key: 96847887
• Report Number: 1820334-2018-00025
• Device Sequence Number: 1
• Product Code: KNA
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)200810(10)8131930
• Combination Product (y/n): N
• PMA/PMN Number: K062438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 03/13/2018

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: No Information
• Device Catalogue Number: J-SOS-100500
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/22/2017
• Initial Date FDA Received: 01/10/2018
• Supplement Dates Manufacturer Received: 02/19/2018
• Supplement Dates FDA Received: 03/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 22 DA
• Patient Weight: 63