MAUDE Adverse Event Report: CARDINAL HEALTH CATH FOLEY SIL ELSTM 30CC 22FR; CATHETER, UROLOGICAL

Model Number	403722
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 they've had an ob physician complain that the balloon ruptured.
Additional Manufacturer Narrative
The device history record (dhr) review for the possible lot number provided was conducted.The lot was manufactured as per the defined device master record.Because a sample was not available for investigation, further investigation could not be conducted.The investigation will be reopened if a sample is received.An actual root cause for the reported condition cannot be specifically identified.No corrective and preventative action (capa) escalation is required at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: CATH FOLEY SIL ELSTM 30CC 22FR
• 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: 17418743
• Report Number: 9611712-2023-00128
• Device Sequence Number: 15679173
• Product Code: KOD
• UDI-Device Identifier: 10192253058383
• UDI-Public: 10192253058383
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2023

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: 403722
• Device Catalogue Number: 403722
• 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: 07/24/2023
• Supplement Date Received by Manufacturer: 07/24/2023
• Initial Report FDA Received Date: 07/28/2023
• Supplement Report FDA Received Date: 08/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown