MAUDE Adverse Event Report: CARDINAL HEALTH, INC DOVER; TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER (KIT)

Model Number	8887605189
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports: the balloon on the catheter snapped (burst).Sometimes immediately after insertion, other times 2-3 days after insertion.The end-user's urine is clean and has no grit.Three occurrences were reported for lot number 23b097fhx, this case represents #3 of the 3 reported cases.The balloon was removed as per normal procedure and the catheter has been replaced.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.H3: device narrative corrected data regulatory attachments narrative corrected data regulatory attachments evaluation comment - the customer stated that the device will not be returned for evaluation but did not provide rationale.
Additional Manufacturer Narrative
The device history record for 23b097fhx was reviewed and no anomalies related to the reported issue were observed.There were no photos or physical samples received for evaluation.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the issue and root cause analysis.At this time, a corrective and preventive action is not deemed necessary.This information will be used for tracking and trending purposes, and we will continue to monitor.Section d4 (unique identifier (udi) #): originally reported as (b)(4).Section d2b product code: originally reported as ezl and should be fcm.Section e1: please disregard the originally reported phone number.The phone number provided was invalid and the customer phone number is unknown.

• Brand Name: DOVER
• Common Device Name: TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER (KIT)
• Manufacturer (Section D): CARDINAL HEALTH, INC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; sragh industrial estate, co, t; offaly ; EI
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 20620144
• Report Number: 1423537-2024-00291
• Device Sequence Number: 12645861
• Product Code: FCM
• UDI-Device Identifier: 00884521166649
• UDI-Public: (01)00884521166649(17)280215(10)23B097FHX
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K024010
• 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): 11/18/2024

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: 8887605189
• Device Catalogue Number: 8887605189
• Device Lot Number: 23B097FHX
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 11/18/2024
• 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