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

Model Number	1614
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
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 when they attempted to inflate the balloon, only 6cc's were able to be injected, so the inflation was incomplete.The user attempted to remove the water, but was not able to.The user removed the product by cutting it.There was no patient injury.
Additional Manufacturer Narrative
H4 device manufacture date was added.The device history record (dhr) review showed all acceptance criteria was met.The sample received was physically inspected.The catheter was dissected to observe any abnormality.It was found there was a flap wall which could cause the non-deflation of the balloon.The reported complaint was confirmed.This event usually occurs when there is inadequate drying between latex layering.No corrective and preventative action (capa) was required.A quality alert was performed for the reported issue and to emphasize the importance of the drying process between latex dips.This complaint will be used for tracking and trending purposes.

• Brand Name: 1614G LTX CATH 5CC 2-WAY 14FR
• 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: 18065914
• Report Number: 9611712-2023-00139
• Device Sequence Number: 15374687
• 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): 01/26/2024

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: 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: 11/01/2023
• Supplement Date Received by Manufacturer: 11/01/2023
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown