MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; TRAY,FOLEY,INSERTION,PVP,10ML,LF,PVP

Catalog Number	DYND10160
Medical Device Problem Codes	Fluid/Blood Leak (1250); Component Missing (2306); Device Misassembled During Manufacturing /Shipping (2912); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
According to the facility, on (b)(6) 2026, a catheter change kit was opened and it was noted that the black cap was not present on the syringe and there was a large amount of air in the syringe, water loss and plunger quite low.
Additional Manufacturer Narrative
According to the facility, on (b)(6) 2026, a catheter change kit was opened and it was noted that the black cap was not present on the syringe and there was a large amount of air in the syringe, water loss and plunger quite low.The facility reported that the kit was not used.The facility further reported that this is the fourth time this same situation has occurred.A new kit was obtained and used.The patient was not affected, and no medical intervention was required.No additional information is available at this time.A sample has been requested for evaluation.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.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 for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.
Additional Manufacturer Narrative
Updated h6: type of investigation (b).

• Brand Name: MEDLINE
• Common Device Name: TRAY,FOLEY,INSERTION,PVP,10ML,LF,PVP
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alyssa reasner ; three lakes drive; northfield, IL 60093-2753 ; 2173279112
• MDR Report Key: 24484789
• Report Number: 1417592-2026-00166
• Device Sequence Number: 10676549
• Product Code: OHR
• UDI-Device Identifier: 10080196997091
• UDI-Public: 10080196997091
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 04/24/2026

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 Catalogue Number: DYND10160
• Device Lot Number: 96925100002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2025
• 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
• Patient Sex: Unknown