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 No Consequences Or Impact To Patient (2199)

Event Date 08/02/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).The event is currently under investigation.

Event Description

It was reported that leakage occurred during a uterine packing procedure for a (b)(6) female patient.The device was being used for uterine bleeding.Leakage was found when the physician was injecting the saline, after placing the device.The physician removed the device from the patient and stopped the bleeding with a urinary catheter.Also, a loophole was found on the balloon that was punctured by haemostatic forceps.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).Investigation - evaluation: a review of the complaint history, drawings, dimensional verification, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, trends, quality control and visual inspection of the returned device was conducted during the investigation.The device is shipped with an instruction for use (ifu) that describes the intended use, this device is to be only used for post-partum hemorrhaging.The visual inspection of the returned device reported leaking at proximal bond.A closer observation was preformed noting a hole in the balloon material.The complaint device was returned therefore, an investigation evaluation was performed.There was no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided and the results of our investigation, there is no indication that a design or process related failure mode contributed to this event.It is feasible to suggest that the device was used outside of its intended design.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.

Event Description

It was reported that leakage occurred during a uterine packing procedure for a (b)(6) female patient.The device was being used for uterine bleeding.Leakage was found when the physician was injecting the saline, after placing the device.The physician removed the device from the patient and stopped the bleeding with a urinary catheter.Also, a loophole was found on the balloon that was punctured by haemostatic forceps.The patient did not require any additional procedures nor 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 INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 5942673
• MDR Text Key: 54424689
• Report Number: 1820334-2016-00824
• Device Sequence Number: 1
• Product Code: KNA
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)190428(10)6924850
• 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: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/15/2016

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: 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: 08/15/2016
• Initial Date FDA Received: 09/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2016
• 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: 79 YR
• Patient Weight: 80