MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CATHETER,FOLEY,SILI-ELAST,LTX,18FR,10ML

Catalog Number	DYND11758H
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported by the nurse that the balloon of the foley catheter, which was in place for 3 weeks, "exploded".The nurse stated that no issues with the balloon were noted when it was tested for inflation prior to insertion and 10 ml saline was used to inflate the balloon when the foley catheter was placed.There was no foley catheter securement device used.A new catheter was inserted and reportedly, the patient is doing well at this time.There was no serious injury or follow-up medical care required.Due to the reported incident and need for foley catheter re-insertion, this medwatch is being filed.The sample was not available to be returned for evaluation.No additional information was provided.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the balloon of the foley catheter "exploded.".

• Common Device Name: CATHETER,FOLEY,SILI-ELAST,LTX,18FR,10ML
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7442927
• Report Number: 1417592-2018-00026
• Device Sequence Number: 16425203
• Product Code: EZL
• UDI-Device Identifier: 10080196726530
• UDI-Public: 10080196726530
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 04/19/2018

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: Nurse
• Device Catalogue Number: DYND11758H
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 04/19/2018
• 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: Other
• Patient Age: 71 YR
• Patient Weight: 174