MAUDE Adverse Event Report: CARDINAL HEALTH DOVER SLVR FOLEY CATH14FR5CC2W; CATHETER, RETENTION TYPE, BALLOON

Model Number	605148IC
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2023
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 that the device was used with a patient having chemo.The patient mentioned that she felt wet.The catheter just came out and they noticed that there was a little slit on the product.Additional information received from the initial reporter on (b)(6) 2023 stated that the slit was on the balloon.
Additional Manufacturer Narrative
Based on the information available to us, we were unable to confirm the event.In the meantime, all information received will be used for further tracking and trending purposes.

• Brand Name: DOVER SLVR FOLEY CATH14FR5CC2W
• Common Device Name: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 22500 ; MX 22500
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 17107454
• Report Number: 9612030-2023-03721
• Device Sequence Number: 2833660
• Product Code: EZL
• UDI-Device Identifier: 10192253031065
• UDI-Public: 10192253031065
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 07/28/2023

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: 605148IC
• Device Catalogue Number: 605148IC
• Device Lot Number: 2024515964
• 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: 06/06/2023
• Supplement Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2020
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown