MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CATHETER,FOLEY,100%SILICONE,14FR,10ML,LF

Catalog Number	DYND11501
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the patient with neurogenic bladder, who has a foley catheter in place for 17 days, required a foley catheter re-insertion after the foley catheter reportedly fell out of the patient with the foley catheter's balloon deflated.Per report, the balloon was tested for inflation and deflation prior to insertion to the patient and no issues were identified at that time.Reportedly, during insertion of the foley catheter, 10 ml of sterile water was used to inflate the foley catheter's balloon.It was reported that the balloon was completely deflated when the foley catheter fell out of the patient.Per report, after the incident happened, the patient used straight catheter at home for several days prior to coming in for foley catheter re-insertion.There was no serious injury reported related to the incident.Due to the reported incident and need for foley catheter re-insertion, 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 the patient required a foley catheter re-insertion after the foley catheter reportedly fell out of the patient with the foley catheter's balloon deflated.

• Common Device Name: CATHETER,FOLEY,100%SILICONE,14FR,10ML,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7558529
• Report Number: 1417592-2018-00048
• Device Sequence Number: 205336
• Product Code: EZL
• UDI-Device Identifier: 10884389034439
• UDI-Public: 10884389034439
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 05/31/2018

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: Other
• Device Catalogue Number: DYND11501
• Device Lot Number: 59217112048
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2018
• Initial Report FDA Received Date: 05/31/2018
• 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: 16 YR
• Patient Weight: 70