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

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: a review of the complaint history, device history record, documentation, and specifications of the device were conducted during the investigation.No complaint device has been returned for investigation, and so a physical examination could not be performed.No photos have been provided.Additionally, a document based investigation evaluation was performed.There was no evidence to suggest the product was not made to specifications.A review of the device history record revealed three nonconformances for lot 7674795 were identified and the devices were scrapped prior to further processing.It should be noted there were two other reported complaints associated with this lot number and that all three complaints have the same failure mode from the same customer.Based on the information provided, the actual root cause is unknown and so no conclusion can be drawn.However, appropriate measures have been initiated to address this failure mode.The quality engineering risk assessment for this failure mode was reviewed and it was determined that no additional risk mitigating activity is required at this time.The appropriate personnel will be notified and we will continue to monitor 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 Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6763871
• MDR Text Key: 81732274
• Report Number: 1820334-2017-02160
• Device Sequence Number: 1
• Product Code: OQY
• 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: 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2017
• 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
• Date Manufacturer Received: 11/15/2017
• 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