MAUDE Adverse Event Report: CARDINAL HEALTH LATX FR 14FR POVIDONE IOD 10OZ; TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER (KIT)

Model Number	3450LF
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
Customer reports: there were multiple occurrences with one patient where the devices were not working.For instance, two device kits were used with no urine return, but with a third try was successful.The next time this patient needed to be catheterized, the same thing happened.The customer has pulled all kits that had the same lot number as the affected products.
Additional Manufacturer Narrative
The device was received for evaluation and the reported condition has been confirmed.  a corrective and preventive action has been initiated to address the reported issue.

• Brand Name: LATX FR 14FR POVIDONE IOD 10OZ
• Common Device Name: TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER (KIT)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 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: 14919595
• Report Number: 9612030-2022-03306
• Device Sequence Number: 2032467
• Product Code: FCM
• UDI-Device Identifier: 10884521009585
• UDI-Public: 10884521009585
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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
• Report Date (Section B): 08/19/2022

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: 3450LF
• Device Catalogue Number: 3450LF
• Device Lot Number: 2210219764
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2022
• Supplement Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 07/05/2022
• Supplement Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown