MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CATHETER,FOLEY,SILI-ELAST,LATEX,6FR,3ML

Catalog Number	DYND11706
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that a (b)(6) week old male was undergoing an outpatient procedure and the clinicians experienced difficulty deflating the balloon in the catheter that the patient had in place.On (b)(6) 2019 the patient had a nuclear medicine study done of his bladder, a fluoroscopic voiding cystourethrogram (vcug) exam was set to follow.The patient had a foley catheter put in place prior to the fluoroscopy exam without incident.The pediatric radiologist filled the bladder with contrast, took the images, and when it was time to deflate the balloon on the foley the balloon was not deflating.The clinician cut just above the hub to see if the fluid would just free flow out of the balloon; however it did not work, no fluid came out.The radiologist was able to use a micropuncture set to then finally release the saline from the balloon and remove the deflated foley from the patient.The catheters are stored on the supply storage shelf in the storage bin at the facility.The catheter was inspected prior to use with no issues detected.The clinician did not pre-inflate the balloon of the catheter prior to the procedure.The clinician did not need to insert a new catheter after the incident.The issue was discover after the patient's procedure was complete.The actual sample involved in the incident was returned for evaluation and the customer reported issue was confirmed.The root cause was determined to be a full occlusion of the inflation lumen in the catheter shaft.Per the facility, there was no serious injury that occurred, there was no change in the patient's treatment plan and there were no adverse effects noted related to the reported issue; however there was medical intervention required to remove the catheter.No additional information is available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
A male patient was undergoing a fluoroscopic voiding cystourethrogram (vcug) exam and the clinicians experienced difficulty deflating the balloon in the catheter that the patient had in place.The radiologist was able to use a micropuncture set to then finally release the saline from the balloon and remove the deflated foley from the patient.

• Common Device Name: CATHETER,FOLEY,SILI-ELAST,LATEX,6FR,3ML
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8821164
• Report Number: 1417592-2019-00109
• Device Sequence Number: 10848535
• Product Code: EZL
• UDI-Device Identifier: 10080196726479
• UDI-Public: 10080196726479
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/24/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: DYND11706
• Device Lot Number: 59218060943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 07/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 4 WK