MAUDE Adverse Event Report: CARDINAL HEALTH 12FR 5CC RED RUBBER COUDE TIP; CATHETER, RETENTION TYPE, BALLOON

Model Number	1512C
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Deflate (4060)
Health Effect - Clinical Code	Pain (1994)
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 the patient came to unc lenoir.A foley catheter was inserted, after levsin sl was given.The patient started complaining of pain so they stopped inflating balloon and tried to deflate the balloon, and started discontinuing foley and realized the balloon still had sterile water in place.They tried different techniques to deflate the balloon and nothing worked.They called the physician and informed them of what happened.The physician instructed them to leave the foley in place and clamp it and send the patient to his office.The physician used an ultrasound to remove the foley.Then they rescheduled for 2 weeks for next treatment.They are concerned the 12 fr coude catheter malfunctioned.
Additional Manufacturer Narrative
Samples were not received for the investigation.A device history record review could not be performed because a lot number was not received with the complaint.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported issue and determine the root cause, therefore a corrective action is not applicable at this time.

• Brand Name: 12FR 5CC RED RUBBER COUDE TIP
• Common Device Name: CATHETER, RETENTION TYPE, BALLOON
• 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: 19233663
• Report Number: 1282497-2024-00511
• Device Sequence Number: 12445745
• Product Code: EZL
• UDI-Device Identifier: 10884521016040
• UDI-Public: 10884521016040
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2024

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: 1512C
• Device Catalogue Number: 1512C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 07/11/2024
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown