MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; ALLERGY TRAY, 27GX0.5", 1 ML 25 SYR/TR

Catalog Number	SYRA101272
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the customer, "after drawing up the serum from the vials and pulling the needle out of the stopper, some needles would dribble solution out the end of the needle, causing a dose changed".The customer continue to report that "nurses then had to reenter the vial to pull additional serum to get the correct dose".The customer also reported that "no incident occurred with patients ".The sample is available 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.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.
Event or Problem Description
According to the customer, "after drawing up the serum from the vials and pulling the needle out of the stopper, some needles would dribble solution out the end of the needle, causing a dose changed".

• Common Device Name: ALLERGY TRAY, 27GX0.5", 1 ML 25 SYR/TR
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093 ; 7403935223
• MDR Report Key: 19060719
• Report Number: 1417592-2024-00466
• Device Sequence Number: 6424210
• Product Code: FMF
• UDI-Device Identifier: 20888277654089
• UDI-Public: 20888277654089
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/08/2024

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: SYRA101272
• Device Lot Number: 230601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 04/08/2024
• 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