MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; TRAY,ADD A CATH,FOLEY,DRAIN BG,10ML SYR

Model Number	DYND11090
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the syringe component is detaching from the foley catheter inflation valve.According to the reporting facility, the syringe "will not lock in place" and that "sediment buildup" has resulted in foley catheter replacements.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, further medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.No sample was returned for evaluation.The reported problem/issue could not be confirmed and a root cause was unable to be determined.In an abundance of caution, and in response to an fda 483 issued for cfn 1417592 on 22-jan-2024, 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 syringe component is detaching from the foley catheter inflation valve.

• Common Device Name: TRAY,ADD A CATH,FOLEY,DRAIN BG,10ML SYR
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 18825628
• Report Number: 1417592-2024-00152
• Device Sequence Number: 7785743
• Product Code: OHR
• UDI-Device Identifier: 40080196991441
• UDI-Public: 40080196991441
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/03/2024

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
• Device Model Number: DYND11090
• Device Lot Number: 96919070001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; Required Intervention
• Patient Sex: Unknown