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

Model Number N/A

Device Problem Leak/Splash (1354)

Patient Problem Coagulation Disorder (1779)

Event Date 01/17/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow up will be provided upon conclusion.

Event Description

It was reported by the user facility that a patient underwent a ¿pressure hemostasis at the uterine cavity¿.The physician stated that after a day of cesarean section, the patient experiences dysfunction of blood coagulation.The operator place the balloon in the patient with curved pliers, when they injecting the saline found the liquid was floating from the vagina, then remove the balloon and injected the saline again, the operator found the balloon leaking.There were no unintended sections of the device that remained inside of the patient¿s body, nor did the patient experience any adverse effects due to this occurrence.No further information was provided.

Manufacturer Narrative

Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, specifications, quality control and visual inspection of the returned device was conducted during the investigation.There is no indication that a design or process related failure mode contributed to this event.A review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.One used balloon was returned for evaluation.A functional test was performed.The balloon had been injected with 60 ml of water when a leak was noted at the proximal end of the balloon.Closer observation noted a small cut in the balloon material.In addition, a review of the device history observed three non-conformances, none of which may have contributed to this incident.A complaint history review showed this complaint to be the only one associated with the complaint lot number.Based on the provided information a definitive root cause cannot be established or reported at this time.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.Per the risk assessment no further action is required.

• 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
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6377320
• MDR Text Key: 69047028
• Report Number: 1820334-2017-00336
• Device Sequence Number: 1
• Product Code: KNA
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)190711(10)7109574
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K062438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/06/2017

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: J-SOS-100500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/04/2017
• Initial Date FDA Received: 03/03/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2016
• 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
• Patient Age: 34 YR
• Patient Weight: 50