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

Catalog Number J-SOSR-100500

Device Problem Inflation Problem (1310)

Patient Problem No Patient Involvement (2645)

Event Date 07/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Pma/510k # k170622.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, "in a simulation the ball of the cook bakri postpartum balloon with rapid instillation components could not be insufflated.The fissure is in the internal catheter." no patient involvement.

Manufacturer Narrative

Investigation ¿ evaluation: a visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed.This included a review of complaint history, the device history record, drawings, quality control data, and specifications.One device was returned for investigation.A functional test was performed, and it was noted that when fluid was inserted into the balloon lumen, fluid backflow out of the other lumen, indicating lumen communication.The lumen communication is preventing the balloon from inflating properly.A review of the device history record found no non-conformances that may have contributed to this failure mode.A complaint history search revealed this is the only complaint associated with lot number 8562164.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.This product is 100 % leak tested.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.There is no indication that a design process or related failure mode contributed to this event.The conclusion for this device issue has been traced to component failure.Per the quality engineering risk assessment, no further action is warranted.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

Event Description

There has been no new information received since the last report was submitted on 31jul2018.

• 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
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 7734427
• MDR Text Key: 115525229
• Report Number: 1820334-2018-02341
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)210204(10)8562164
• Combination Product (y/n): N
• Reporter Country Code: GT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/04/2021
• Device Catalogue Number: J-SOSR-100500
• Device Lot Number: 8562164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1