MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; 1LYR 16FR 10ML SILVER DB TRAY

Catalog Number	DYND160416
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that an unidentified number of foley catheters "leak urine after being inserted for just three days." reportedly, the foley catheters were switched to a different brand.It is unknown where the leaking urine was noticed coming from (the patient's urethra, the foley catheter tubing itself, connection to the drainage port, etc.).Despite good faith efforts to obtain additional information, the reporting facility was unable or unwilling to provide any further patient, product, or procedural details.There was no serious injury or follow-up care reported related to the event.Due to the reported incident and need for foley catheter exchange, this medwatch is being filed.The sample is not available to be returned for evaluation.A root cause could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that an unidentified number of foley catheters "leak urine after being inserted for just three days.".

• Common Device Name: 1LYR 16FR 10ML SILVER DB TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8046993
• Report Number: 1417592-2018-00121
• Device Sequence Number: 16557617
• Product Code: OHR
• UDI-Device Identifier: 10884389096079
• UDI-Public: 10884389096079
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 11/07/2018

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: DYND160416
• Device Lot Number: 18EBG807
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 11/07/2018
• 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