MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TRAY,FOLEY,SILVER,2-WAY,16FR,10ML,LF

Catalog Number	DYND140216
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the urinary catheter's drainage bag "clogged" with sediment and the urinary catheter was replaced.After multiple good-faith attempts, the facility contact was unable or unwilling to provide additional patient or product information related to this incident.It is unknown how long the urinary catheter was inserted for prior to noticing the reported "clog." no impact to the patient or to the patient's stability was reported.No additional details related to this incident were reported to the manufacturer.No sample was returned to the manufacturer for evaluation.A root cause for the reported incident could not be determined.Due to the need for medical intervention to replace the urinary catheter, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the urinary catheter's drainage bag "clogged" with sediment and the urinary catheter was replaced.
Additional Manufacturer Narrative
The manufacturer received communication from the facility contact with information related to the reported incident.According to the customer contact, the urinary catheter was in place for four (4) days before it was found to no longer be flowing.Reportedly, the urinary catheter was removed and the facility's staff member noted that "the balloon had ruptured." the urinary catheter was replaced with a new urinary catheter.No further medical intervention or follow-up care reported.No impact to the patient or the patient's stability reported.No sample was returned to the manufacturer for evaluation.A root cause for the reported product issue could not be determined.If additional relevant information becomes available another supplemental medwatch will be filed.

• Common Device Name: TRAY,FOLEY,SILVER,2-WAY,16FR,10ML,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 8103426
• Report Number: 1417592-2018-00130
• Device Sequence Number: 11170341
• Product Code: OHR
• UDI-Device Identifier: 10080196183418
• UDI-Public: 10080196183418
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 12/10/2018

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: DYND140216
• Device Lot Number: 18GBI179
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/01/2018
• Supplement Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 11/26/2018
• Supplement Report FDA Received Date: 12/10/2018
• 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