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

Model Number	1614
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2023
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 before use, when the balloon was inspected, the water leaked.No patient use.
Additional Manufacturer Narrative
H4 device manufacturing date added the device history record (dhr) review was performed.The batch was manufactured as per defined device master record.All acceptance criteria were met, and this batch was released meeting all the acceptance criteria.The sample was received and physically inspected.No leakage was found, and no changes were found to the inflated balloon.The reported condition could not be replicated.The actual root cause cannot be determined.No corrective and preventative action (capa) is necessary currently.This complaint will be used for tracking and trending purposes.
Additional Manufacturer Narrative
The device history record (dhr) review showed the batch was manufactured per defined records and all acceptance criteria was met.The sample has not been received at the manufacturing site for evaluation.The complaint will be reopened and investigated when the sample is received.An actual root cause for the reported condition cannot be specifically identified.No action plan is required currently.This complaint will be used for 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 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: 16723845
• Report Number: 9611712-2023-00120
• Device Sequence Number: 7225827
• Product Code: KOD
• UDI-Device Identifier: 10884521016224
• UDI-Public: 10884521016224
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/06/2023

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: 1614
• Device Catalogue Number: 1614
• Device Lot Number: 2251U11QX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 04/11/2023; 04/11/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 05/15/2023; 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2022
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown