MAUDE Adverse Event Report: MEDLINE - MEXICALI MEDLINE; VASCULAR ACCESS PACK

Catalog Number	DYNJ58963B
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the luer lock end on the syringes is misshapen.The needle or extension tubing will not screw onto it.We are having to open up another syringe.We were unable to use that syringe and had to open a new one.The misshapen syringes were not used on any patients.There were no reports of death, serious injury, medical intervention, or follow up care.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
The luer lock end on the syringes is misshapen.The needle or extension tubing will not screw onto it.We are having to open up another syringe.

• Brand Name: MEDLINE
• Common Device Name: VASCULAR ACCESS PACK
• Manufacturer (Section D): MEDLINE - MEXICALI; calle circuito del desierto 71; baja california 21383 ; MX 21383
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25658852
• Report Number: 1423395-2026-00325
• Device Sequence Number: 10379580
• Product Code: OEZ
• UDI-Device Identifier: 10198459394935
• UDI-Public: 10198459394935
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/29/2026

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: DYNJ58963B
• Device Lot Number: 26BMI446
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2026
• 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