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

Catalog Number	PAIN2145
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on (b)(6) 2025 "the physician introduced the needle into the patient at the l3/4 level, a fluoroscopic image was taken in the ap position, the c-arm was then moved into the lateral position so the physician could continue to advance the needle, at this point, the physician slightly retracted the needle to readjust the position, during retraction, the needle broke off approximately 2-3 cm under the patient's skin".Per the facility the needle "was never near the epidural space".Per the facility the "the physician used a scalpel to slightly cut the skin, tweezers were used in an attempt to retract the needle, the tweezers were able to grasp the needle but would slip off".Per the facility "the decision was made to transport the patient via ems to the hospital; a surgical team took the patient into the operating room where the needle was removed under general anesthesia without incident".Per the facility the patient is "recovering well".The device is not available for evaluation.No additional information is available at this time.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
The needle broke off approximately 2-3 cm under the patient's skin.

• Common Device Name: CUSTOM ESI TRAY-BYRNE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 22053263
• Report Number: 1417592-2025-00235
• Device Sequence Number: 20140805
• Product Code: OFT
• UDI-Device Identifier: 10198459062810
• UDI-Public: 10198459062810
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 05/20/2025

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: PAIN2145
• Device Lot Number: 24KBA316
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2024
• 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 Age: 65 YR
• Patient Sex: Female
• Patient Weight: 136 KG