MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CATHETER,FOLEY,SILI-ELAST,LATEX,8FR,3ML

Catalog Number	200269084
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during removal of the foley catheter that was in place for 3 days for urinary retention, the foley catheter's balloon would not deflate requiring a 0.016 inches peripherally inserted central catheter wire be inserted on the balloon channel to successfully deflate the balloon.The foley catheter was reportedly successfully removed with the foley catheter's tip and deflated balloon intact.Per report, during insertion by surgeon, 3 ml of saline was placed to inflate the balloon of the foley catheter.Per the reporting facility, balloon testing prior to insertion of foley catheter is not in their policy.Reportedly, during attempt to deflate the balloon, only 1 ml of saline was aspirated from the balloon port and remaining saline could not be removed even after the foley catheter's ports were cut.It was reported that there was no serious injury that occurred related to this incident.The patient was reportedly able to void after the incident and has been discharged to home.Due to the reported incident and in an abundance of caution, this medwatch is being filed.The sample is not available to be returned for evaluation.A root cause cannot be determined at this time.No additional information is available.If additional relevant information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during removal of the foley catheter, the foley catheter's balloon would not deflate.

• Common Device Name: CATHETER,FOLEY,SILI-ELAST,LATEX,8FR,3ML
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7560451
• Report Number: 1417592-2018-00050
• Device Sequence Number: 2194520
• Product Code: EZL
• UDI-Device Identifier: 10080196726486
• UDI-Public: 10080196726486
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/01/2018

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: Physician
• Device Catalogue Number: 200269084
• Device Lot Number: 59215060771
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2018
• Initial Report FDA Received Date: 06/01/2018
• 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: 5 YR
• Patient Weight: 15