MAUDE Adverse Event Report: PRODUCTOS MEDLINE; LUMBAR PUNCTURE TRAY

Catalog Number	DYNDH1160
Medical Device Problem Codes	Defective Component (2292); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility, on 8/14/2025, the 20ml syringe is defective, "the rubber stopper inside the syringe, that is attached to the top of the plunger has been "falling off" inside when sliding it in/out.Radiologist was pulling back on the plunger of the syringe; the rubber end came off inside and the suction was immediately released." 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
According to the facility, on 8/14/2025, the 20ml syringe is defective, "the rubber stopper inside the syringe, that is attached to the top of the plunger has been "falling off" inside when sliding it in/out.Radiologist was pulling back on the plunger of the syringe, the rubber end came off inside and the suction was immediately released.".

• Common Device Name: LUMBAR PUNCTURE TRAY
• Manufacturer (Section D): PRODUCTOS MEDLINE; productos medline s.a. de c.v.; blvd world trade center no.106; nuevo laredo, tamaulipas 88285 ; MX 88285
• Manufacturer Contact: alyssa reasner ; 3 lakes dr; northfield, IL 60093
• MDR Report Key: 23031678
• Report Number: 3004122598-2025-00008
• Device Sequence Number: 13187051
• 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
• Report Date (Section B): 09/11/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: DYNDH1160
• Device Lot Number: 25ABE419
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2025
• 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