MAUDE Adverse Event Report: CARDINAL HEALTH 1622G LTX CATH 5CC 2-WAY 22FR; CATHETER, UROLOGICAL

Model Number	1622
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.The device was manufactured between september 27, 2021 and february 24, 2022.A sample was not received for the investigation.Because a sample was not returned, we were unable to perform functional and visual evaluations to confirm the reported condition and determine the root cause.If a sample is received at a later date, the complaint will be reopened, and the investigation will be updated accordingly.A corrective action is not applicable at this time.Functional testing and visual inspections are performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.
Event or Problem Description
The customer reported that the foley catheter, which was being used as an suprapubic (sp) tube, fell out of the patient.It had a leak in the balloon.The patient had to go back to the or to have an sp tube replaced.Per additional information provided on march 07, 2023, the incident occurred 5-6 months ago.The patient returned to the or because the suprapubic tube tract closed off after the tube fell out.

• Brand Name: 1622G LTX CATH 5CC 2-WAY 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: 16645177
• Report Number: 9611712-2023-00117
• Device Sequence Number: 5367771
• Product Code: KOD
• UDI-Device Identifier: 10192253026177
• UDI-Public: 10192253026177
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 1622
• Device Catalogue Number: 1622
• Device Lot Number: 2099U15QX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 03/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown