MAUDE Adverse Event Report: COOK INC COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS; OQY INTRAUTERINE BALLOON

Model Number G24237

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2018

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: k170622.(b)(4).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 that on (b)(6) 2018 while in the birth room, it was impossible to use the (bakri balloon) device because the balloon was punctured.They changed the device.Also reported, this was an emergency and thus stress and waste of time.There were no clinical consequences.Additional information was received on 16jul2018.The patient was treated with nalador and the bakri balloon for post partum hemorrhage.When the first balloon did not inflate, they changed to a 2nd bakri balloon to stop the bleeding.There were no adverse effects on the patient due to this occurrence.

Event Description

Additional information has been received.It was reported the patient was given syntocinon, hexacil, and nalador during the procedure.They used a second bakri balloon to achieve hemostasis.Postpartum hemorrhage stopped.The device was thrown away.

Manufacturer Narrative

The product carton confirming reported lot number was returned.There was no device inside the carton.There is no change to the previous investigation conclusion; cause not established.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 is no new event information to report.

Manufacturer Narrative

H6 - method codes: 4114, device not returned.H6 - conclusion codes: 4315, cause not established.The complaint device was not returned for an evaluation and no photographs 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 complaint history, the device history record, drawings, quality control data, and specifications.The device history record was reviewed and noted there are no conformances that may have contributed to this incident.A review of complaint history records revealed this complaint to be the only one associated with complaint lot number 8433291.There is no indication that a design process or related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Measures have been initiated to address the reported 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

No additional information has been received since the last report was submitted on 08aug2018.

• Brand Name: COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS
• Type of Device: OQY INTRAUTERINE BALLOON
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7691286
• MDR Text Key: 114430404
• Report Number: 1820334-2018-02053
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)201211(10)8433291
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/22/2018

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 Expiration Date: 12/11/2020
• Device Model Number: G24237
• Device Catalogue Number: J-SOSR-100500
• Device Lot Number: 8433291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2019
• Initial Date Manufacturer Received: 07/03/2018
• Initial Date FDA Received: 07/16/2018
• Supplement Dates Manufacturer Received: 08/03/2018; 08/20/2018; 05/07/2019
• Supplement Dates FDA Received: 08/08/2018; 08/22/2018; 06/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 35 YR