MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DBD-SYR W/NDLE,HYPODERM,LL,22GX1", 3ML

Catalog Number	SYR103225
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility on (b)(6) 2024, the user was "drawing up a medication when the syringe separated from the needle and sprayed partial medication on to the provider".Per the facility the user "did ensure the needle was tight".Per the facility the patient received a partial dose of medication, however, no treatment or serious injury occurred.No additional information is available at this time.The sample was requested for evaluation.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.In an abundance of caution, and in response to an fda 483 issued for (b)(4) on 22-jan-2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
According to the facility on (b)(6) 2024 the user was "drawing up a medication when the syringe separated from the needle and sprayed partial medication on to the provider".

• Common Device Name: DBD-SYR W/NDLE,HYPODERM,LL,22GX1", 3ML
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 20495061
• Report Number: 1417592-2024-00909
• Device Sequence Number: 4096518
• Product Code: FMF
• UDI-Device Identifier: 40080196449539
• UDI-Public: 40080196449539
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 10/21/2024

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: SYR103225
• Device Lot Number: 89723060001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 10/21/2024
• 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: 29 YR
• Patient Sex: Male