MAUDE Adverse Event Report: PRODUCTOS MEDLINE, S.A. DE C.V.; LUMBAR PUNCTURE TRAY

Catalog Number	DYNDH1160
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the rubber stopper, inside the syringe is "falling off".Due to this, a new syringe was used.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.
Event or Problem Description
Rubber stopper in syringe is "falling off".
Additional Manufacturer Narrative
Updated g3, g6, h6.

• Common Device Name: LUMBAR PUNCTURE TRAY
• Manufacturer (Section D): PRODUCTOS MEDLINE, S.A. DE C.V.; blvd. world trade center no. 1; parque industrial, nuevo laredo 88285 ; MX 88285
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 23833239
• Report Number: 3004122598-2025-00015
• Device Sequence Number: 17410252
• Product Code: OFF
• UDI-Device Identifier: 10889942425136
• UDI-Public: 10889942425136
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 12/30/2025

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: DYNDH1160
• Device Lot Number: 25EB0399
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 12/28/2025
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/21/2025
• 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