MAUDE Adverse Event Report: CARDINAL HEALTH 3560 KENGUARD SILCATH 5CC 16FR; CATHETER, UROLOGICAL

Model Number	3560
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
Per customer, the patient stated that the catheter broke/ ripped apart while in use.Each catheter broke in a similar area (not far from the insertion point).This all happened within the same month resulting in the patient needing a catheter insertion 3 times within a 3-week period.The patient needed to seek medical assistance to retrieve the 2nd broken catheter.Several attempts to gather information from the customer were made.To date, no response has been received.If additional pertinent information becomes available, the report will be updated.
Additional Manufacturer Narrative
The lot number provided by the customer is not a valid lot number.It is believed by the manufacturing site after reviewing the lot tracking system, that the lot number should be 3137k12qx, and not 313k12qk.The device history record (dhr) review for lot 3137k12qx showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.No sample was available for evaluation.Without a sample we are unable to perform a thorough follow up investigation to include functional and visual evaluation to determine the root cause or implement any corrective action.If a sample is received later, this complaint will be reopened, and the investigation updated to reflect our findings.This complaint will be used for tracking and trending purposes.

• Brand Name: 3560 KENGUARD SILCATH 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: 19273712
• Report Number: 9611712-2024-00007
• Device Sequence Number: 12636178
• Product Code: KOD
• UDI-Device Identifier: 10192253026344
• UDI-Public: 10192253026344
• 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): 06/19/2024

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: 3560
• Device Catalogue Number: 3560
• Device Lot Number: 313K12QK
• 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: 04/25/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 06/19/2024
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown