MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; DBD-OUTPATIENT 2 TO 5 YEARS

Catalog Number	DYNDV2464A
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
"y-piece broken off".
Additional Manufacturer Narrative
It was reported that while administering medication, it was noted that the "iv was no longer attached to fluids".Due to this, leaking occurred.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: DBD-OUTPATIENT 2 TO 5 YEARS
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; blvd. world trade center no. 1; nuevo laredo, nuevo laredo 88285 ; MX 88285
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 23632097
• Report Number: 3004122598-2025-00013
• Device Sequence Number: 21405373
• Product Code: LRS
• UDI-Device Identifier: 10195327065911
• UDI-Public: 10195327065911
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 11/24/2025

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
• Device Catalogue Number: DYNDV2464A
• Device Lot Number: 25GBD983
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/05/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown