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

Model Number G24237

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510k #: k170622.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported, during an unknown procedure using a cook bakri postpartum balloon with rapid instillation components, the physician found that the balloon was leaking.It is unknown how the procedure was completed.No adverse effects to the patient have been reported due to this occurrence.Additional information has been requested and will be included in a follow-up report when/if that information is received.

Event Description

Additional information was received 20nov2019: it was reported, a second, same type device was used to complete the procedure.Blood loss prior to and after device placement was1,000 cc's.

Manufacturer Narrative

H6: ec method code: communication/interviews investigation/evaluation: a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, the instructions for use, quality control data, and specifications.One device was returned for investigation.The returned packaging confirms the reported complaint device lot number.The visual examination confirmed the catheter was returned in used condition.A dark substance was observed inside the catheter above the balloon.Inside the balloon there was a red/ brown substance on the top and side of the material.Under magnification, grasper marks, several punctures and two large holes were identified in the balloon material.A search of the complaint database revealed no other complaints related to this lot number.The device history record (dhr) was reviewed and no non-conformances were found during the production of this lot number.Because there were no non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.The instructions for use (ifu) included with this device provides the following information to the user related to the reported failure mode: how supplied upon removal from the package, inspect the product to ensure no damage has occurred.The complaint was confirmed based on customer testimony and investigation of the returned device.Damage to the balloon is use related.Based on the available information, the most likely cause of the event was determined to be unintended use error.The risk analysis for this failure mode was reviewed, and it was determined that no additional risk mitigating activity is required.We will continue our monitoring of 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.

• 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: 9284293
• MDR Text Key: 165238425
• Report Number: 1820334-2019-02797
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)191103(10)7416258
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/03/2019
• Device Model Number: G24237
• Device Catalogue Number: J-SOSR-100500
• Device Lot Number: 7416258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Date Manufacturer Received: 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1