MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; NEEDLE,22GX1.5",REG,BEVEL

Catalog Number	SYR100227
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility the needle detached from the syringe and "shot off into the patient stomach".
Additional Manufacturer Narrative
According to the facility the needle detached from the syringe and "shot off into the patient stomach".Per the facility this occurred during a surgical procedure and had to be removed from inside the patient's body.Per the facility the patient did not incur a serious injury related to the reported incident.The sample was returned for evaluation however the defect was unconfirmed.No additional information is available at this time.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: NEEDLE,22GX1.5",REG,BEVEL
• 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: 21147982
• Report Number: 1417592-2025-00022
• Device Sequence Number: 21106702
• Product Code: FMI
• UDI-Device Identifier: 40080196305538
• UDI-Public: 40080196305538
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 01/14/2025

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?: Yes
• Device Catalogue Number: SYR100227
• Device Lot Number: 240520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2024
• Initial Report FDA Received Date: 01/14/2025
• 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: Required Intervention; Other
• Patient Sex: Unknown