MAUDE Adverse Event Report: CARDINAL HEALTH FOLY CATH 100 SLCON 3CC 10FR; TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER (KIT)

Model Number	8887603101
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that when she inflates the balloon there was a hole in it.Per customer, she always tests prior to insertion.Each time, she tested and didn¿t notice a hole and inserted only to have the balloon slowly deflate and fall out, resulting in a wet mess.There was no harm reported.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
Section d1 / d2 (brand name): originally reported as foly cath 100 slcon 5cc 12fr and should be foly cath 100 slcon 3cc 10fr.Section d4 (model number and catalog number): originally reported as 8887605122 and should be 8887603101, (unique identifier (udi) #): originally reported as 10884521016651 and should be 10884521016620.
Additional Manufacturer Narrative
The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The device was manufactured on 03-feb-2023.One sample was received for evaluation.Upon visual and functional inspection, the reported issue was not confirmed.At this time, a corrective and preventive action is not deemed necessary.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.

• Brand Name: FOLY CATH 100 SLCON 3CC 10FR
• Common Device Name: TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER (KIT)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 17999715
• Report Number: 1282497-2023-10800
• Device Sequence Number: 6754226
• Product Code: FCM
• UDI-Device Identifier: 10884521016620
• UDI-Public: 10884521016620
• 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,Followup
• Report Date (Section B): 04/22/2024

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: 8887603101
• Device Catalogue Number: 8887603101
• Device Lot Number: 2302318
• 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: 10/13/2023
• Supplement Date Received by Manufacturer: 10/13/2023; Not provided
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 11/28/2023; 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown