MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; 25G WHITACRE SPINAL TRAY

Catalog Number	DYNJRA1740A
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility, on (b)(6) 2026, crna was attempting to place a spinal block prior to a scheduled c-section.The crna felt a "snap/pop" while attempting to get to the correct space, immediately pulled the needle out of the patient and noted that the needle had broken leaving a portion of the needle inside the patient.
Additional Manufacturer Narrative
According to the facility, on (b)(6) 2026, crna was attempting to place a spinal block prior to a scheduled c-section.The crna felt a "snap/pop" while attempting to get to the correct space, immediately pulled the needle out of the patient and noted that the needle had broken leaving a portion of the needle inside the patient.Procedure was stopped, patient taken out of the or.Required transfer to another facility for delivery of her baby and then surgical removal of the needle.Per the facility, there was a delay in delivery, transfer to a higher level of care.Patient required a 2nd surgical procedure to have the needle removed from the patient's back.The facility reports that the patient has been discharged home.No additional information at this time.It has been determined that the reported event caused or contributed to a death or serious injury.Based on the information reviewed, this is a reportable event as defined under 21 cfr 803.3.

• Brand Name: MEDLINE
• Common Device Name: 25G WHITACRE SPINAL TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alyssa reasner ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25334730
• Report Number: 1417592-2026-01940
• Device Sequence Number: 9767901
• Product Code: OJH
• UDI-Device Identifier: 10195327088934
• UDI-Public: 10195327088934
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/29/2026

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: DYNJRA1740A
• Device Lot Number: 26AMD201
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/14/2026
• 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: 23 YR
• Patient Sex: Female
• Patient Weight: 131 KG
• Patient Ethnicity: Hispanic