MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; DBD-PACK VASCULAR AMC

Catalog Number	DYNJT3128
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the facility, the syringe did not attach to the fluid system well and different syringes had to be used.There was no impact to the patient.
Additional Manufacturer Narrative
According to the facility, the syringe did not attach to the fluid system well and different syringes had to be used.There was no impact to the patient.A sample is available 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.Demographics were not given, but 0kg was entered since the submission portal will not accept this field blank.
Additional Manufacturer Narrative
Corrected: d9: sample received date.Updated d4: lot number.Corrected h6: b and c.

• Brand Name: MEDLINE
• Common Device Name: DBD-PACK VASCULAR AMC
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 23907981
• Report Number: 1423395-2025-00210
• Device Sequence Number: 9093438
• Product Code: OEZ
• UDI-Device Identifier: 10198459307652
• UDI-Public: 10198459307652
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 02/13/2026

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
• Device Catalogue Number: DYNJT3128
• Device Lot Number: 25HLA555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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