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

Model Number N/A

Device Problems Break (1069); Leak/Splash (1354)

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

Event Date 08/11/2016

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.(b)(4).The event is currently under investigation.

Event Description

It was reported during post-partum hemorrhage the operator placed the bakri balloon in the patient and when injecting the saline a leak was noted and the balloon reported to be broken.The balloon was removed and another used to finish the procedure.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.

Manufacturer Narrative

(b)(4).Investigation - evaluation: a review of the complaint history, device history record, specifications, and quality control was conducted during the investigation.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is 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.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

Event Description

It was reported during post-partum hemorrhage the operator placed the bakri balloon in the patient and when injecting the saline a leak was noted and the balloon reported to be broken.The balloon was removed and another used to finish the procedure.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 INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 5946632
• MDR Text Key: 54574498
• Report Number: 1820334-2016-00957
• Device Sequence Number: 1
• Product Code: KNA
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)180930(10)6249034
• 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: 08/19/2016

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?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/19/2016
• Initial Date FDA Received: 09/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/14/2016
• Date Device Manufactured: 09/30/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Weight: 65