MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CATHETER,FOLEY,100%SILICONE,6FR,1.5ML,LF

Catalog Number	DYND11552
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that immediately after insertion of a foley catheter for urinary retention, balloon leaking was noted on the y-site (drainage ports) resulting in removing the already inserted foley catheter and replacing with a new foley catheter.Reportedly, prior to insertion to the patient, the foley catheter that leaked was tested for inflation and deflation and there was no leak on the balloon noted at that time.Per report, 5 ml of saline was used to inflate the balloon and 5 ml of saline was taken out of the balloon during deflation.The patient was reportedly discharged the next day after the incident with no further issues noted.There was no serious injury reported related to this event.Due to the reported need for foley catheter re-insertion, this medwatch is being filed.The sample was returned for evaluation and the reported foley catheter leaking was not verified.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that a new foley catheter was inserted after the foley catheter's balloon was noted leaking.

• Common Device Name: CATHETER,FOLEY,100%SILICONE,6FR,1.5ML,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7740927
• Report Number: 1417592-2018-00077
• Device Sequence Number: 1589188
• Product Code: EZL
• UDI-Device Identifier: 10884389034415
• UDI-Public: 10884389034415
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/01/2018

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: Health Professional
• Device Catalogue Number: DYND11552
• Device Lot Number: 592170049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2018
• Initial Report FDA Received Date: 08/01/2018
• 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: Other
• Patient Age: 5 YR
• Patient Weight: 16