MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; NEEDLE,HYPODERM,SAFETY,25GX1.5

Catalog Number	SSN100257
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility on 9/30, "i was trying to administer a flulaval vaccine.I secured the medline 25g, 1.5" sure-snap safety needle to the pre-filled syringe, as is typical for vaccine administration, and went to administer the vaccine.As i pressed in the plunger of the syringe, the needle detached from the syringe and the vaccine wasted outside of the patient's shoulder.".
Additional Manufacturer Narrative
According to the facility on 9/30, "i was trying to administer a flulaval vaccine.I secured the medline 25g, 1.5" sure-snap safety needle to the pre-filled syringe, as is typical for vaccine administration, and went to administer the vaccine.As i pressed in the plunger of the syringe, the needle detached from the syringe and the vaccine wasted outside of the patient's shoulder.Seeing the needle was still imbedded in the patient's deltoid muscle, i quickly removed the needle, applied the safety cap, and wasted it in the sharps container to prevent any further accidents.Using a different brand of 25g, 1.5" needles, i was able to successfully administer the vaccine to the patient.He is a 58-year-old male, weighing approximately 174 pounds.After contacting the patient today, he denies any complications from the flu shot on monday.He states he is doing fine, enduring typical side effects from the influenza vaccine".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,HYPODERM,SAFETY,25GX1.5
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 20569756
• Report Number: 1417592-2024-00924
• Device Sequence Number: 7816416
• Product Code: FMI
• UDI-Device Identifier: 20193489031994
• UDI-Public: 20193489031994
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 10/30/2024

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
• Device Catalogue Number: SSN100257
• Device Lot Number: 89721090001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 10/30/2024
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 79 KG