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

Catalog Number J-SOSR-100500

Device Problem Component Missing (2306)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

The customer reported that they had a defective cook bakri postpartum balloon with rapid instillation components.As reported, the device was missing a piece.Another bakri was used.No further event detail has been provided to date.Additional patient, product and event details have been requested.There has been no information provided that alleges the patient experienced any adverse effects.

Manufacturer Narrative

Reportability decision reassessed 28aug2019.Case has been reassessed as not-reportable.There were no adverse effects to the patient reported in this case.There have been no precedent setting events reported where a missing component has led to a serious injury or death.Due diligence was executed with four attempts to obtain additional details regarding the patient and event with no response from the customer.Risk document lists risk severity for this situation as severity of 4-negligible harm-harm not requiring medical intervention, and no reported cases of risk severity higher than this rating.There was no adverse event or reportable device malfunction.

Manufacturer Narrative

Investigation ¿ evaluation: the cook bakri postpartum balloon with rapid instillation components was not returned.No photograph or imaging was provided for review.Without the complaint device, a physical investigation was not able to be completed.A document based investigation has been performed.A review of the instructions for use, quality control data, and specifications was conducted.The device history record was not able to be reviewed due to insufficient lot information.A review of complaint history records was not able to be performed as the lot number was not available.There is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Based on the provided information a definitive root cause cannot be established.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• 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: 6799870
• MDR Text Key: 82945595
• Report Number: 1820334-2017-02526
• Device Sequence Number: 1
• Product Code: OQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: J-SOSR-100500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/28/2019
• 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