MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - MEXICALI (MXC); ULTRASOUND MSK TRAY

Catalog Number	DYNDH1535B
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the facility on (b)(6) 2025, the syringe was "damaged".
Additional Manufacturer Narrative
According to the facility on (b)(6) 2025, the syringe was "damaged".Per the facility they were "able to drop new syringes to draw up medications," and no serious injury or medical intervention incurred.The sample was requested for evaluation.No additional information is available at this time.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 (b)(4) on (b)(6) 2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.
Additional Manufacturer Narrative
Updated: b4, g3, g6, h2, h3, h6.Sample was not returned, however, pictures of the impacted product were provided.Per review of the photos provided, the report of the damaged syringe was confirmed.Pack build was reviewed and no issues were noted that would have contributed to the reported issue.At this time the root cause is a vendor product issue.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: ULTRASOUND MSK TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - MEXICALI (MXC); calle circuito del desierto; parque industrial del desierto; mexicali, baja california 21383 ; MX 21383
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 23645068
• Report Number: 3015173212-2025-00003
• Device Sequence Number: 21289504
• Product Code: LRO
• UDI-Device Identifier: 10198459249907
• UDI-Public: 10198459249907
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 12/08/2025

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: DYNDH1535B
• Device Lot Number: 25GMG478
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2025
• 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
• Patient Sex: Unknown