MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; CATHETER,FOLEY,SILVER,16FR,10ML,LF

Catalog Number	DYND141016
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, the foley was noted to have "black spots" inside the foley and the customer is concerned that it was "possibly mold".The customer reported an additional foley was required to be inserted due to the visual defect.Sample was requested for return evaluation.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.
Event or Problem Description
According to the customer, the foley was noted to have "black spots" inside the foley and the customer is concerned that it was "possibly mold".

• Common Device Name: CATHETER,FOLEY,SILVER,16FR,10ML,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17482608
• Report Number: 1417592-2023-00330
• Device Sequence Number: 7144744
• Product Code: EZL
• UDI-Device Identifier: 10080196182145
• UDI-Public: 10080196182145
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2023

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: DYND141016
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2023
• Supplement Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 10/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown