MAUDE Adverse Event Report: COOK INC COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS; KNA INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC

Catalog Number J-SOSR-100500

Device Problems Inflation Problem (1310); Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/04/2017

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 area manager reported during a postpartum hemorrhage case, the patient was treated with a cook bakri postpartum balloon with rapid instillation components.The bakri was inserted into the uterus and inflated.The user noticed that the balloon was slowly deflating.The balloon could not be inflated.They kept the bakri in place as it was stopping the bleeding.The patient was treated with nalador.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional patient and event information has been requested.

Manufacturer Narrative

Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, specifications, and quality control was conducted during the investigation.No issues were found related to the reported complaint.The cook bakri postpartum balloon with rapid instillation components was not returned for evaluation.No photos have been provided.Without the complaint device, a physical investigation was not able to be completed.The device history record was reviewed and no non-conformances were noted.A review of complaint history for this product/lot number combination revealed there have been no other complaints received associated with the complaint lot number 7837276.Based on the investigation evaluation, 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; device integrity prior to shipping.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.Based on the provided information and the investigation evaluation the actual root cause is unknown and a conclusion cannot be drawn.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

Manufacturer Narrative

Investigation ¿ evaluation: the cook bakri postpartum balloon with rapid instillation components was returned for evaluation.A functional test was performed and no leaks were noted.The stopcock does not appear to leak.The customers reported difficulty could not be recreated in the lab.Based on the device evaluation and information provided, the actual root cause of customer report cannot be determined.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: KNA INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6833825
• MDR Text Key: 84260839
• Report Number: 1820334-2017-02777
• Device Sequence Number: 1
• Product Code: KNA
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)200417(10)7837276
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K062438
• 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,Followup
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2017
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2017
• 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