MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC DOVER; CATHETER, UROLOGICAL

Model Number	1621
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2024
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 that a leak was observed upon inflating the balloon prior to indwelling to the patient.There was no patient use.The issue was discovered during preparation.
Additional Manufacturer Narrative
The lot number was provided, and the device history record was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The sample received 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.The root cause identified was due to bubbles being trapped in the latex, causing the area to not be covered with latex throughout the dipping process.A nonconformance was opened to address the issue of bubbles being trapped in the latex.The reported lot number was manufactured prior to the implementation of the nonconformance; therefore, no further action is required.This complaint will be used for qa tracking and trending purposes.

• Brand Name: DOVER
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH 200, LLC; mediquip sdn.bhd. padang lati,; kangar, perlis ; MY
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 20185239
• Report Number: 1423537-2024-00148
• Device Sequence Number: 8704179
• Product Code: KOD
• UDI-Device Identifier: 10192253026160
• UDI-Public: (01)10192253026160(17)281116(10)3322U14QX
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K860484
• 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): 10/25/2024

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: 1621
• Device Catalogue Number: 1621
• Device Lot Number: 3322U14QX
• 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: 09/02/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown