MAUDE Adverse Event Report: CARDINAL HEALTH CATH FOLEY SIL ELSTMR 5CC 16FR; CATHETER, UROLOGICAL

Model Number	402716
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that a defective catheter was inserted.The catheter was not draining and could not be flushed.The patient has a neobladder, so this could have been serious, but thankfully it leaked around the catheter.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
Representative samples were received at the plant for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Upon a visual and functional evaluation of the samples, the reported issue was not confirmed; they were able to be inflated/deflated and there was no blockage to the drainage.A root cause was unable to be determined.

• Brand Name: CATH FOLEY SIL ELSTMR 5CC 16FR
• 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: 18350232
• Report Number: 9611712-2023-00150
• Device Sequence Number: 6222095
• Product Code: KOD
• UDI-Device Identifier: 10884521016163
• UDI-Public: 10884521016163
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2024

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: 402716
• Device Catalogue Number: 402716
• Device Lot Number: 3081S12QX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2023
• Supplement Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown