MAUDE Adverse Event Report: CARDINAL HEALTH 14FR SILVER DRAIN BAG FOLEY TR; COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER

Model Number	6144ICLL
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2023
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 they experienced a foley catheter dislodgement that appeared to be related to a leaking balloon.
Additional Manufacturer Narrative
Samples were not received for the investigation.A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported issue and determine the root cause, therefore a corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.If a sample is received at a later date, this complaint will be reopened for further investigation.This complaint will be used for tracking and trending purposes.

• Brand Name: 14FR SILVER DRAIN BAG FOLEY TR
• Common Device Name: COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• 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: 16955911
• Report Number: 9612030-2023-03701
• Device Sequence Number: 7040841
• Product Code: KNX
• UDI-Device Identifier: 10884521009127
• UDI-Public: 10884521009127
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/26/2023

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: 6144ICLL
• Device Catalogue Number: 6144ICLL
• 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: 05/12/2023
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 05/18/2023
• Supplement Report FDA Received Date: 05/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown