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

Additional information: customer does not know where the products are.Customer advised they had mailed them, but they do not have a tracking number to locate them.Investigation ¿ evaluation: 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.A review of complaint history, the device history record, manufacturing instructions, quality control data and specifications was performed.The device history record was reviewed and one non-conformance was noted.The non-conformance identified was for markings, coverage insufficient and involved three (3) items.These items were scrapped.A review of complaint history for this device lot noted there have been two additional complaints for the same issue.All three complaints are from the same customer.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.Based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined.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.

• 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: 6788742
• MDR Text Key: 82894674
• Report Number: 1820334-2017-02518
• 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: 02/07/2018

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: 01/23/2018
• Supplement Dates FDA Received: 02/07/2018
• 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