MAUDE Adverse Event Report: CARDINAL HEALTH 2822 LTX CATH 30CC 3-WAY 22FR; CATHETER, UROLOGICAL

Model Number	2822
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
Customer reports: one day since indwelling, the product disengaged.The balloon deflated.An attempt was made to insert water again, and a gradual leak from the balloon area was confirmed.
Additional Manufacturer Narrative
The device history record for each lot affected was review, showed that manufacturing and inspection product was performed as per applicable procedures and validated process.Five photos were submitted for evaluation.Based on the observation of the photos, it confirms that a balloon formed in the tube which caused it to break.A gemba walk was performed at the manufacturing site where the process was reviewed.All process and controls were properly followed, including sub-assemblies, finished product assembly, packaging and inspections performed on the product.In addition, qc inspections are performed to the product for material release; and production personnel performs a 100% visual inspection during the packaging process, in order to detect and discard any identified defects.At this time the device has not been returned thus, an exact root cause could not be determined and minimizing the ability to further investigate and confirm that the issue was related to the device.The product design safety, performance, and effectiveness remain the same or better.No new hazards, hazardous situations, harms, or failure modes are introduced due to this event, and the risk profile remains unchanged that would drive updates to the current risk management files.Based on the above assessment, no further actions are being pursued as a result of the complaint.
Additional Manufacturer Narrative
A sample was received for evaluation, and it was physically inspected.The balloon was inflated with 10ml as per requirement and a balloon leak was confirmed.A pinhole was found at the balloon edge area.This pinhole was caused by the bubbles trapped in the latex and when dipping this bubble attached to the catheter, thus, causing the bubble area was not covered with latex throughout the dipping process.A 100% inspection of the balloon was performed for all catheters; however, the inspection used an air inflation method instead of a water inflation method.The pressure exerted by air was different than water.Thus, the reported condition could not be detected during 100% inspection.A non-conformance (nc) was issued to address bubbles trapped in the latex.This nc was closed on 7 sep 2023.The affected batch was manufactured before the implementation of this nc.Thus, the action taken was considered effective.

• Brand Name: 2822 LTX CATH 30CC 3-WAY 22FR
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street, mansfield, ma; 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: 19470051
• Report Number: 9611712-2024-00008
• Device Sequence Number: 16992833
• Product Code: KOD
• UDI-Device Identifier: 10884521016613
• UDI-Public: 10884521016613
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/03/2024

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: 2822
• Device Catalogue Number: 2822
• 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: 06/04/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 06/05/2024
• Supplement Report FDA Received Date: 08/28/2024; 09/03/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown