MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CATHETER,FOLEY,100%SILICONE,20FR,30ML,LF,

Catalog Number	DYND11534
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the end-user has chronic medical issues and is on a weekly catheter exchange due to recurrent urinary tract infections/urosepsis.The nurse reported that the catheter was inserted on (b)(6) 2019 and the end-user noticed on (b)(6) 2019 that the catheter was leaking.The patient went to the emergency room, had unspecified labs drawn and a urinalysis performed with no infection noted.The end user was discharged back home and the home health nurse went to the patient's home to remove the catheter and place a new catheter.The home health nurse reported that prior to the initial catheter insertion the balloon of the catheter was pre-inflated to check the integrity of the balloon prior to insertion, contrary to the manufacturer's instructions for use.There was no further intervention required for the patient at this time.The actual sample involved in the reported incident is not available to be returned for evaluation.There was no serious injury, follow-up medical care or additional medical intervention required related to the incident, however medical intervention to replace the initial catheter was necessary.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
It was reported that the urinary catheter was leaking.The urinary catheter was removed and replaced.
Additional Manufacturer Narrative
Product code: ezl.

• Common Device Name: CATHETER,FOLEY,100%SILICONE,20FR,30ML,LF,
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8607543
• Report Number: 1417592-2019-00072
• Device Sequence Number: 11305176
• Product Code: EZL
• UDI-Device Identifier: 10884389034569
• UDI-Public: 10884389034569
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYND11534
• Device Lot Number: 59218060943
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/03/2019
• Supplement Date Received by Manufacturer: 05/03/2019
• Initial Report FDA Received Date: 05/14/2019
• Supplement Report FDA Received Date: 05/14/2019
• 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: 79 YR
• Patient Weight: 97