MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - SPT MEDLINE; DBD-PACEMAKER PACK

Catalog Number	DYNJ63874G
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported on 03/26 that the needle detached from the syringe during use.The same needle was subsequently attached to a different syringe and functioned without issue, indicating the issue was associated with the syringe.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 issue.In an abundance of caution, and in response to an fda 483 issued for cfn (b)(4) on 22-jan-2024, this medwatch is being filed for the reported issue.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported on 03/26 that the needle detached from the syringe during use.The same needle was subsequently attached to a different syringe and functioned without issue, indicating the issue was associated with the syringe.

• Brand Name: MEDLINE
• Common Device Name: DBD-PACEMAKER PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - SPT; 1170 s northpoint boulevard; waukegan IL 60085 6757
• Manufacturer Contact: nithla mathivanan ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24886238
• Report Number: 1423395-2026-00084
• Device Sequence Number: 18600613
• Product Code: OEZ
• UDI-Device Identifier: 10195327565947
• UDI-Public: 10195327565947
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• 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,Followup
• Report Date (Section B): 05/21/2026

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: DYNJ63874G
• Device Lot Number: 25HLA545
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2026
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 04/15/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2025
• 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