MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CATHETER,FOLEY,COUDE,LATEX,20FR,10ML

Catalog Number	DYND11220
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the patient's chronic indwelling catheter that was in place for one month was scheduled to be removed when the balloon could not be deflated and no sterile water was coming out of the balloon port.Reportedly, the foley catheter was initially cut below the balloon port and then below the y intersection but on both attempts, no sterile water was coming out.It was reported that ultrasound confirmed balloon was still inflated and then it was decided that in order to deflate the balloon, patient would require cystoscopy to puncture the foley catheter's balloon using a small needle.Reportedly, 10 ml of sterile water was used to inflate the balloon during insertion and the foley catheter's balloon was not tested for inflation and deflation at the time of insertion.There was no serious injury reported related to the incident and the patient is doing well at this time.Due to the reported incident and in an abundance of caution, this medwatch is being filed.The foley catheter's shaft was returned for evaluation and the reported product issue was confirmed.No definitive root cause could 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 the patient required cystoscopy to puncture the foley catheter's balloon that would not deflate.

• Common Device Name: CATHETER,FOLEY,COUDE,LATEX,20FR,10ML
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7514898
• Report Number: 1417592-2018-00028
• Device Sequence Number: 1626552
• Product Code: EZL
• UDI-Device Identifier: 10080196029198
• UDI-Public: 10080196029198
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Physician Assistant
• Type of Report: Initial
• Report Date (Section B): 05/15/2018

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 Assistant
• Device Catalogue Number: DYND11220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 05/15/2018
• 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: 56 YR