MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; TRAY, CSE 17GHUST 27GWHIT, W/RX

Catalog Number	PAIN9028
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2025 the needle broke inside the patient while attempting to administer "local anesthesia" prior to an epidural placement.The customer reported due the reported incident the patient delivered her baby without the epidural while laying "on her side because she couldn't lay on her back".The customer reported after the delivery, the patient had a "lumbar exploration with removal of foreign body" requiring anesthesia.No additional information is available at this time.It has been determined that the reported event caused or contributed to serious injury, 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
According to the customer, on (b)(6) 2025 the needle broke inside the patient while attempting to administer "local anesthesia" prior to an epidural placement.
Additional Manufacturer Narrative
Update to d9: device returned.Update to h3: device evaluated.Update to h6: type of investigation.

• Common Device Name: TRAY, CSE 17GHUST 27GWHIT, W/RX
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 21403599
• Report Number: 1417592-2025-00086
• Device Sequence Number: 21212012
• Product Code: OFT
• UDI-Device Identifier: 10193489295689
• UDI-Public: 10193489295689
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2025

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: PAIN9028
• Device Lot Number: 24DLA392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 19 YR
• Patient Sex: Female
• Patient Weight: 85 KG