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	04/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Updated the field d4: lot number - lot number was not originally reported however the product sample was returned and confirmed the actual lot number which has been added to this field.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
Customer reports: when the cuff of the catheter was checked to be used intraoperatively in advance.The injection test of the fixative was successful, but there was strong resistance to the syringe at the time of the recovery test.When injected again and retrieved, the cuff withered.A preoperative test was performed with a separate catheter, and there was no problem, so it was used for surgery.We experienced a similar case last week, but we have not secured the product itself.The actual product will be 1ea, but we will send it.Duration of use: found in pre-use test.Per additional information received on 04/12/24, the complaint indicated that the cuff withered and it has been clarified that the balloon deflated.A complaint will be created for the similar case mentioned in this report.
Additional Manufacturer Narrative
Based on the information available to us, we were unable to confirm the event.This batch was manufactured as per defined device master record.All acceptance criteria met, and this batch was release meeting all the acceptance criteria.The sample received was physically inspected and tested for its functionality.There was no sign of strong resistance to syringe found during inflation deflation test on the sample.No blockage was found on the drainage lumen for all samples.No action plan will be taken since the reported condition could not be replicated.The actual root cause could not be determined.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: 19111192
• Report Number: 9611712-2024-00004
• Device Sequence Number: 8283497
• 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,Followup
• Report Date (Section B): 05/31/2024

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: 3181U11QX
• 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: 04/10/2024
• Supplement Date Received by Manufacturer: 04/10/2024; Not provided
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 04/16/2024; 05/31/2024
• 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