MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; ESI TRAY

Catalog Number	PAIN2152
Medical Device Problem Codes	Difficult to Remove (1528); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Updated d9: returned to manufacturer and date returned.Updated h3: device evaluated by manufacturer.Updated h6: type of investigation (b).Updated h6: investigation findings (c).Updated h6: investigation conclusions (d).
Event or Problem Description
According to the facility, "the stylet would not remove from the needle.The needle was removed and the doctor had to stick the patient again with another needle.".
Additional Manufacturer Narrative
According to the facility, "the stylet would not remove from the needle.The needle was removed and the doctor had to stick the patient again with another needle." facility reports no harm to patient directly.No additional information at this time.The product has been requested for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: ESI TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; 3 lakes dr; northfield IL 60093
• Manufacturer Contact: alyssa reasner ; 3 lakes dr; northfield, IL 60093
• MDR Report Key: 23482000
• Report Number: 1417592-2025-00601
• Device Sequence Number: 18724614
• Product Code: OFT
• UDI-Device Identifier: 10198459065248
• UDI-Public: 10198459065248
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 12/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: PAIN2152
• Device Lot Number: 25BBU126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2025
• 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