MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; SYRINGE, LUER LOCK, STERILE, 10ML

Catalog Number	SYR110010Z
Medical Device Problem Code	Decrease in Suction (1146)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Plunger came out of syringe.
Additional Manufacturer Narrative
It was reported that the plunger came out of the syringe.In an abundance of caution, and in response to an fda 483 issued for cfn (b)(4) on (b)(6) 2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.

• Common Device Name: SYRINGE, LUER LOCK, STERILE, 10ML
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 19093037
• Report Number: 1417592-2024-00488
• Device Sequence Number: 7141286
• Product Code: FMF
• UDI-Device Identifier: 30080196310191
• UDI-Public: 30080196310191
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 04/11/2024

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?: No
• Device Catalogue Number: SYR110010Z
• Device Lot Number: 230630, 89723080001, 897230800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2024
• Initial Report FDA Received Date: 04/11/2024
• 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
• Patient Sex: Unknown