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 12/03/2018

Event Type  malfunction  

Manufacturer Narrative

Occupation: non-healthcare professional.Pma/510(k) #: k170622.Device code: stopcock, fluid 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

It was reported the user planned to use the j-sos-100500 to stop postpartum uterine bleeding as the patient lost 500ml blood after delivery by caesarean section.The user found a leakage issue at the stopcock while injecting saline, but at the stage the balloon has been inflated a bit in uterus and could not be retracted.In order to stop bleeding the user decided to cut the stopcock at the distal end where it was leaking and joined the proximal end of the stopcock with a catheter to continue to inflate the balloon.The bleeding eventually stopped.As reported, the patient did not require any additional procedures and the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation ¿ evaluation a visual inspection and functional testing of the returned device was conducted.A video was also provided for review.A document based investigation included a review of the video, complaint history, the device history record, drawings, instructions for use, quality control data, and trends.One device was returned for investigation.The returned packaging confirms lot number 9161158.A leak test was performed and determined there is a leak at the stopcock.A review of the provided video shows the fittings leaking.The device history record was reviewed and no non-conformances were identified that would be related to the reported failure.A complaint history search revealed this is the only complaint associated with lot number 9161158.The instructions for use (ifu) provides the proper warnings, precautions, and instructions for use.The cause of the leaking was not established.Measures have been initiated to address this failure mode.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database 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 new information received since the last report was submitted.

• 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: 8170790
• MDR Text Key: 131142624
• Report Number: 1820334-2018-03783
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)210913(10)9161158
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,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 Expiration Date: 09/13/2021
• Device Catalogue Number: J-SOS-100500
• Device Lot Number: 9161158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Date Manufacturer Received: 01/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 75