MAUDE Adverse Event Report: CARDINAL HEALTH 6600 PEDIATRIC URINE METER; URINOMETER, MECHANICAL

Model Number	6600-
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the luer lock connection pieces are faulty.They were completely blocked so weren't draining the fluid.No injuries occurred.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record was reviewed, and indicated that no abnormal process conditions were present during the manufacturing of the product that could have led to the reported issue.The device history record review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.The device was manufactured on october 28, 2021.One digital image was received for the investigation.The digital image was visually inspected according to procedure, but the reported issue could not be confirmed without a physical sample to evaluate.The investigation was carried out with the multifunctional team.The process was reviewed, and it was verified that all processes and controls were carried out correctly, including the packaging and all inspections carried out on the product.No abnormal conditions were found that could trigger the reported condition.If a sample is received at a later date, the investigation will be updated accordingly.A corrective action is not applicable at this time.We will continue to monitor customer complaint and feedback notifications for adverse trends that require immediate attention.This complaint will be used for tracking and trending purposes.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed and indicated that no abnormal process conditions were present during the manufacturing of the product that could have led to the reported issue.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.The device was manufactured on october 28, 2021.Two decontaminated physical samples without the lot number were received at the manufacturing site for investigation in addition to the photos provided.The samples were visually inspected, and the reported condition was confirmed; the pvc tubes had excess solvent in the valve and the pvc tube, and the valve do not drain.After investigation of the failure mode, a definitive root cause could not be determined.The assembly process has been developed in accordance with the approved specifications.As a containment measure staff was notified of the reported condition, with the purpose of raising staff awareness.We will continue to monitor customer complaints and feedback notifications for adverse trends that require immediate attention.

• Brand Name: 6600 PEDIATRIC URINE METER
• Common Device Name: URINOMETER, MECHANICAL
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• 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: 14688889
• Report Number: 9612030-2022-03281
• Device Sequence Number: 4832574
• Product Code: EXR
• UDI-Device Identifier: 10884521002111
• UDI-Public: 10884521002111
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/19/2022

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 Model Number: 6600-
• Device Catalogue Number: 6600-
• Device Lot Number: 2129303764
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2022
• Supplement Date Received by Manufacturer: 06/08/2022; 06/08/2022
• Initial Report FDA Received Date: 06/14/2022
• Supplement Report FDA Received Date: 07/26/2022; 12/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown