MAUDE Adverse Event Report: CARDINAL HEALTH 1614G LTX CATH 5CC 2-WAY 14FR; CATHETER, UROLOGICAL

Model Number	1614
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
Customer reports: the product was used for a gynecologic operation.When attempting to remove the device from the patient¿s body after the operation, a syringe was used, however, it failed to drain the sterilized water from the balloon left in the body.The inflation lumen was cut off, however, it also did not resolve the issue.The product was finally removed from the patient's body with the use of a wire.It took 45 minutes for this whole removal procedure after the operation itself.There was no patient injury.
Additional Manufacturer Narrative
This batch was manufactured as per defined device master record and this batch was released meeting all the acceptance criteria.The product sample was received for evaluation.Based on complaint description, the reported condition was found to be non-deflation.The sample received was already cut into 2 parts consisting of funnel part and shaft part.The sample was physically inspected.The sample could not be inflated through the inflation valve since it was already cut.Thus, a syringe needle was used to inflate the balloon through the inflation lumen.The balloon can be inflated normally, and no blockage was found.The balloon was also deflated by removing the syringe needle from the inflation lumen.The balloon can be deflated normally without any obstruction.Thus, the reported condition could not be replicated.This batch was manufactured as per defined device master record and this batch was released meeting all the acceptance criteria.The sample received was already cut into 2 pieces therefore the physical investigation could not replicate the reported condition.A corrective/preventative action (capa) escalation is not required as the the risk was at a reduced level.A quality alert will be issued to raise awareness on this type of complaint.

• Brand Name: 1614G LTX CATH 5CC 2-WAY 14FR
• 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: 17898552
• Report Number: 9611712-2023-00137
• Device Sequence Number: 3453936
• Product Code: KOD
• UDI-Device Identifier: 10884521016224
• UDI-Public: 10884521016224
• 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
• Report Date (Section B): 11/01/2023

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: 1614
• Device Catalogue Number: 1614
• 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: 09/21/2023
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 11/01/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown