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	07/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the balloon would not deflate.It was only placed less than 2 hours before the attempted removal.Additional information received from the initial reporter stated that the pa finally placed a guidewire into the balloon channel and deflated it therefore no invasive procedure needed to deflate the balloon.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.A sample was not returned for evaluation.Since the sample was not returned, an analysis of the device could not be conducted therefore the reported issue was unable to be confirmed.This complaint will be reopened and further investigated if a sample is received at a later date.

• 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; padang lati mukim paya batu 5; jalan santan; kangar, perlis ; MY
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 15099073
• Report Number: 9611712-2022-00112
• Device Sequence Number: 11815582
• Product Code: KOD
• UDI-Device Identifier: 10884521016224
• UDI-Public: 10884521016224
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2022

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 Expiration Date: 09/12/2026
• Device Model Number: 1614
• Device Catalogue Number: 1614
• Device Lot Number: 1343U11QX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2022
• Supplement Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 07/25/2022
• Supplement Report FDA Received Date: 10/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown