MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; SYRINGE, LUER LOCK, STERILE, 3ML

Catalog Number	SYR103010Z
Medical Device Problem Codes	Leak/Splash (1354); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility on (b)(6) 2024, "i went to push the syringe after checking that it was on securely, then the needle dislodged from the syringe making the medication spill everywhere.I cleaned his skin with alcohol, then i placed a dry intact dressing.The patient needed to be restuck.The patient was okay and just got the same 15 minute post- injection monitoring that he would have had anyways.He is doing much better.No further issues arose." 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 cfn 1417592 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, "i went to push the syringe after checking that it was on securely, then the needle dislodged from the syringe making the medication spill everywhere.".

• Common Device Name: SYRINGE, LUER LOCK, STERILE, 3ML
• 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: 19929632
• Report Number: 1417592-2024-00789
• Device Sequence Number: 14143224
• Product Code: FMF
• UDI-Device Identifier: 30080196310160
• UDI-Public: 30080196310160
• 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): 08/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: SYR103010Z
• Device Lot Number: 89723060001
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown