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

Model Number	DYND11552
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Parent of end user alerted rn of leaking foley catheter.It was reported, "the foley catheter snapped off above the balloon port while still secured with dressing in the patient leaking urine." urology resident examined end user, and contacted attending physician.It was reported a new foley catheter was inserted with the use of a guidewire and end user's surgical site assessed.It was reported end user's surgical site was redressed and foley reconnected to a new leg bag, with observed urine flow.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.A sample has been returned, (medline quality receive one (1, ea) sample of the 6 fr.1.5ml 100% silicone pediatric foley catheter (dynd11552, lot 592190703).The sample was received in an opened, used condition.Please note that the sample received differs from the item originally reported.Dynd11706 was originally documented as the defective item; however, dynd11552 was received).The suspected root cause is a tensile force applied to catheter detaching it from the y-junction.Due to the need for medical intervention during the reported incident, this medwatch is being filed.If additional relevant information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported the foley catheter "snapped off above the balloon port while still secured with dressing in the patient." catheter was reported to be leaking.Catheter removed and replaced.
Additional Manufacturer Narrative
Additional information received by user facility not known at the time of mdr submission.Date of incident: (b)(6) 2020.Patient's age: (b)(6).

• Brand Name: MEDLINE
• Common Device Name: CATHETER,FOLEY,100%SILICONE,6FR,1.5ML,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• MDR Report Key: 10451871
• Report Number: 1417592-2020-00090
• Device Sequence Number: 16448643
• Product Code: EZL
• UDI-Device Identifier: 10884389034415
• UDI-Public: 10884389034415
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DYND11552
• Device Catalogue Number: DYND11552
• Device Lot Number: 592190703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Initial Date Received by Manufacturer: 08/05/2020
• Supplement Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 08/27/2020
• 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: 12 MO
• Patient Weight: 9