MAUDE Adverse Event Report: CARDINAL HEALTH 1614G LTX CATH 5CC 2-WAY 14FR; CATHETER, UROLOGICAL

Model Number	1614
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports: the balloon did not deflate properly to remove from the patient.The customer had to cut the catheter and insert a guide wire to deal with the situation.The period of use is unknown.There is no patient injury.No sample return due to being discarded.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.H3: device evaluation comment - the customer stated that the device will not be returned for evaluation because the device was discarded.
Additional Manufacturer Narrative
Based on the information available to us, we were unable to confirm the event.In the meantime, all information received will be used for further tracking and trending purposes.

• Brand Name: 1614G LTX CATH 5CC 2-WAY 14FR
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street, mansfield, ma; 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: 19108148
• Report Number: 9611712-2024-00005
• Device Sequence Number: 20650176
• Product Code: KOD
• UDI-Device Identifier: 20192253026136
• UDI-Public: 20192253026136
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/06/2024

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: 1614
• Device Catalogue Number: 1614
• Device Lot Number: 3356911QX
• 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: 04/12/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 06/06/2024
• 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