MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CATHETER,FOLEY,SILI-ELAST,LTX,16FR,10ML

Catalog Number	DYND11756
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the patient's home health rn was unable to deflate the urinary catheter balloon for removal.Reportedly, the patient was taken to a local hospital's emergency department (ed).While in the ed, unidentified blood work, a urinalysis, and an electrocardiogram (ecg) were obtained.No results were provided to the manufacturer.Reportedly, the ed physician was also unable to deflate the urinary catheter balloon.After multiple attempts to aspirate fluid from the urinary catheter balloon, a urologist was consulted.Reportedly, the urologist removed the urinary catheter with the balloon still inflated.The urinary catheter was in place for nine (9) days prior to the reported incident.While the patient was still in the ed, a new urinary catheter was inserted by the urologist.The patient was discharged home from the ed with follow-up with the urologist and unidentified treatment for "an infection".A sample was not available to be returned to the manufacturer for evaluation.A root cause for the reported incident could not be determined.Due to the need for medical intervention and follow-up care, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the urinary catheter balloon was unable to be deflated during removal.

• Common Device Name: CATHETER,FOLEY,SILI-ELAST,LTX,16FR,10ML
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 8366252
• Report Number: 1417592-2019-00027
• Device Sequence Number: 18939990
• Product Code: EZL
• UDI-Device Identifier: 10080196726523
• UDI-Public: 10080196726523
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/25/2019

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: DYND11756
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 02/25/2019
• 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: 81 YR
• Patient Weight: 79