MAUDE Adverse Event Report: CARDINAL HEALTH 6308 2000ML DRAIN BG W SPOUT; COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER

Model Number 6308

Device Problem No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2021

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reported they attach the bag to their stoma but the bag fully expands at night and will not allow urine to go in.This started in recent months, and forces the patient to wake up frequently to release the air.No further details were able to be obtained as the initial reporter's information was not provided upon intake.

Manufacturer Narrative

The device history record was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the issue described by the customer.The device history record review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.One used sample without its original packaging with lot number 2023121764 was received for evaluation.A visual inspection of the received sample was carried out according to the procedure.In addition, a functional test was completed per procedure.The bag was filled to its maximum capacity (2000 ml) without observing any condition that prevented its filling therefore the reported issue was not confirmed.An investigation was carried out with the multifunctional team; all processes were reviewed and all processes and controls were found to be properly followed, including packaging and all inspections performed on the product.No abnormal conditions were found that could trigger the reported condition.Based on all available information, the reported issue could not be confirmed and a root cause could not be determined therefore a corrective and preventative action is not required at this time.We will continue to monitor the process, customer complaints and feedback notifications for any adverse trends that require immediate attention.

• Brand Name: 6308 2000ML DRAIN BG W SPOUT
• Type of Device: COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER
• Manufacturer (Section D): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12987516
• MDR Text Key: 282499857
• Report Number: 9612030-2021-03120
• Device Sequence Number: 1
• Product Code: KNX
• UDI-Device Identifier: 10884521002050
• UDI-Public: 10884521002050
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 6308
• Device Catalogue Number: 6308
• Device Lot Number: 2023121764
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Sex: Male