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)
Date of Event	03/02/2023
Type of Reportable Event	Malfunction
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 catheter which was used as a suprapubic tube fell out of the patient.The catheter had a leak in the balloon.There was no patient injury.Per additional information provided on march 07, 2023 the patient was an outpatient and the catheter was replaced without incident after it fell out.
Additional Manufacturer Narrative
When the sample was inflated with 10ml of water as recommended by the specification, a leak in the balloon was observed.A root cause analysis indicated that this issue occurred as a result of low sdt of reinforcement latex which causes weak latex properties and bonding.Actions have been taken to address the reported condition.All information received will be used for further tracking and trending purposes.

• 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: 16646844
• Report Number: 9611712-2023-00119
• Device Sequence Number: 20363564
• 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,Followup
• Report Date (Section B): 04/28/2023

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: 1622
• Device Catalogue Number: 1622
• Device Lot Number: 2099U15QX
• 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: 03/02/2023
• Supplement Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown