MAUDE Adverse Event Report: CARDINAL HEALTH FOLY CATH SEC 22F 5CC 3WAY; CATHETER, UROLOGICAL

Model Number	8887688227
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported after installation on the patient, the urinary catheter does not empty the bladder.With this catheter, the bladder gets full but does not empty.
Additional Manufacturer Narrative
Additional information: e1: the initial reporter's facility and address were added.
Additional Manufacturer Narrative
The device history record (dhr) review showed the lot was manufactured as per defined device master records.Twelve samples were received.They were all unopened and unused samples.All samples were opened from each package and physically inspected.The balloon was able to be inflated and deflated as per normal function.Each sample was tested for its drainage and no blockage can be observed.The reported condition could not be replicated in all 12 samples received.The actual root cause cannot be determined because the reported condition could not be replicated.No action plan is required.This complaint will be used for tracking and trending purposes.

• Brand Name: FOLY CATH SEC 22F 5CC 3WAY
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; mediquip sdn.bhd. padang lati,; kangar, perlis ; MY
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 18355397
• Report Number: 9611712-2023-00151
• Device Sequence Number: 6426410
• Product Code: KOD
• UDI-Device Identifier: 30884521017072
• UDI-Public: 30884521017072
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 03/07/2024

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: 8887688227
• Device Catalogue Number: 8887688227
• Device Lot Number: 2161533QX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2023
• Supplement Date Received by Manufacturer: 12/04/2023; 12/04/2023
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 12/19/2023; 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown