MAUDE Adverse Event Report: COOK INC BAKRI TAMPONADE BALLOON CATHETER; OQY INTRAUTERINE BALLOON

Catalog Number J-SOS-100500

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2018

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: k170622.Device code: stopcock, leak is not labeled.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

As reported by the customer, the bakri balloon (j-sos-100500) was placed in a patient who had a caesarean section, and the balloon was inflated with 200ml of fluid.24 hours later, the user found the balloon was already deflated as the fluid in the balloon had leaked out.Only 10ml of fluid was left in the balloon and the drape was wet.After the balloon was removed from the patient, it was inflated again.No leak from the balloon was detected, but the blue tab/handle of the stopcock had turned to open position.The patient's hemorrhage was arrested successfully and no additional treatment was required.No adverse consequences were reported to the patient as a result of this occurrence.

Manufacturer Narrative

Investigation ¿ evaluation.The complaint device was not returned for an evaluation.No photos were provided.Without the complaint device, a device failure analysis was unable to be performed.A document based investigation was conducted including a review of the instructions for use, quality control data, and trends.A review of the device history record was unable to be performed as the complaint device lot number was not provided.A review of complaint history for the complaint device lot number could not be performed without the complaint device lot number.The instructions for use contains cautions related to this failure mode: the device should not be left indwelling for more than 24 hours.Patients in whom this device is being used should be closely monitored for signs of worsening bleeding and/or disseminated intravascular coagulation (dic).Patient monitoring is an integral part of managing postpartum hemorrhage.Monitor the patient continuously for signs of increased bleeding and uterine cramping.Possible causes for this issue include supplier deficiency, manufacturing quality deficiency, damage to the device during use, or damage during the 24 hours after placement.There is not enough information to confirm a specific cause; the cause of the reported event could not be established.A quality engineer risk assessment concluded no risk reduction activities are required.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

There has been no additional information received since the last report was submitted.

Event Description

Additional information received 07jan2019 and 08jan2019.It is unknown if the patient had a planned cesarean section, or if the cesarean section was required due complications from the delivery.Concomitant medications reported as given during the delivery: 0.5mg of neosynesine (phenylephrine) : intravenous dosage, once.0.5mg of atropine : intravenous dosage, once 0.5mg of droleptan (droperidol) : intravenous dosage, twice 1g of cefazolin sodium with 100ml of saline : intravenous drip, once atonin-o injection (oxytocin) with 100ml of saline : continuous intravenous drip (twice) 800ml of voluven (hes) and 500ml of physio140 injection as transfusion the patient's total estimated blood loss was 1596ml, and she received 600ml of autologous blood transfusion.The bakri balloon used in this event was placed trans-abdominally and the stopcock was removed prior to balloon placement.Tamponade was achieved with the bakri balloon placed during this event.No pictures, videos, images, or operative reports can be provided.Additional clarifying information has been requested regarding the patient and event.At the time of this report, this additional information has not been received.

• Brand Name: BAKRI TAMPONADE BALLOON CATHETER
• Type of Device: OQY INTRAUTERINE BALLOON
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8169076
• MDR Text Key: 131142699
• Report Number: 1820334-2018-03689
• Device Sequence Number: 1
• Product Code: OQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: J-SOS-100500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 60