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 Problem Partial Blockage (1065)

Patient Problem No Consequences Or Impact To Patient (2199)

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 while preparing the cook bakri postpartum balloon with rapid installation components for bakri placement for hemorrhage, the white part used to spike the bag seemed to be occluded.This was discovered before the bakri was placed.The tubing was unable to be primed, therefore the balloons were not inflated.The bakri was not used on the patient and the procedure was completed using a different bakri.There was no patient harm or consequence.

Manufacturer Narrative

Investigation ¿ evaluation: the cook bakri postpartum balloon with rapid instillation components was not returned for evaluation.As reported, this device was not able to be located by the user facility.No photos have been provided.Without the complaint device, a physical investigation was not able to be completed.A document-based investigation/evaluation was performed.A review of complaint history, the device history record, quality control data, and specifications was conducted.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.The device history record was reviewed and one non-conformance was noted for three (3) devices with the issue of "markings, coverage insufficient".These items were all scrapped.A review of complaint history for this product/lot number combination revealed there have been two other complaints received associated with the complaint lot number 7674795.All complaints received for this lot were received from the same customer and were for the same failure mode.Based on the provided information and the investigation evaluation the actual root cause is unknown and no conclusion could 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.

• 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: 6788311
• MDR Text Key: 82958485
• Report Number: 1820334-2017-02517
• Device Sequence Number: 1
• Product Code: KNA
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)200214(10)7674795
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/09/2018

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: No Information
• Device Catalogue Number: J-SOSR-100500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/17/2017
• Initial Date FDA Received: 08/11/2017
• Supplement Dates Manufacturer Received: 12/27/2017
• Supplement Dates FDA Received: 01/09/2018
• Date Device Manufactured: 02/14/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1