MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; DBD-SYRINGE,LUER LOCK,STERILE,60ML,PUMPC

Catalog Number	SYR160010PCZ
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Leaking around syringe plunger.
Additional Manufacturer Narrative
It was reported that "propofol leaking around the plunger and the plunger becoming very hard to push.When putting the syringe in the propofol infuser, the infuser is unable to push the plunger of the syringe and begins alarming that there is an occlusion".No additional information was provided.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: DBD-SYRINGE,LUER LOCK,STERILE,60ML,PUMPC
• 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: 20030884
• Report Number: 1417592-2024-00815
• Device Sequence Number: 11529166
• Product Code: FMF
• UDI-Device Identifier: 20193489181637
• UDI-Public: 20193489181637
• 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): 08/21/2024

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: SYR160010PCZ
• Device Lot Number: 89723020003, 89723030001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 08/22/2024
• 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 Sex: Unknown