MAUDE Adverse Event Report: CARDINAL HEALTH CATH FOLEY SIL ELSTMR 5CC 14FR; CATHETER, UROLOGICAL

Model Number	402714
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2023
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 the probe was used to perform urinary catheterization.The probe was clamped with hemostatic forceps during the procedure.When the procedure was completed and the removal of the probe was required, the balloon could not be emptied of its contents.The probe had to be cut upstream of where the forceps were placed in order to empty the contents of the balloon.
Additional Manufacturer Narrative
The device history record (dhr) review showed the batch was manufactured as per the defined device master record.All acceptance criteria were met, and this batch was released meeting all the acceptance criteria.No sample was received for evaluation.The root cause for the reported condition could not be identified.No action plan will be taken.The complaint will be reopened if a sample is received.This complaint will be used for tracking and trending purposes.

• Brand Name: CATH FOLEY SIL ELSTMR 5CC 14FR
• 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: 17556673
• Report Number: 9611712-2023-00131
• Device Sequence Number: 19742710
• Product Code: KOD
• UDI-Device Identifier: 10192253026627
• UDI-Public: 10192253026627
• 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
• Report Date (Section B): 09/15/2023

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: 402714
• Device Catalogue Number: 402714
• Device Lot Number: 3029S11QX
• 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: 08/10/2023
• Supplement Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 09/15/2023
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown