MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline; NEEDLE,HYPODERM,SAFETY, 25GX5/8

Model Number	SSN100253
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medication leaked requiring second administration.
Additional Manufacturer Narrative
According to the customer contact, "the luer-lock hubs are cracked, but were not noted until administering the vaccines, which caused the vaccine to squirt out from the side of the hub instead of being administered into the patient.This resulted in the patient needing to be revaccinated and expensive vaccine wastage." no additional details were provided.A sample was not returned for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.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.

• Brand Name: Medline
• Common Device Name: NEEDLE,HYPODERM,SAFETY, 25GX5/8
• 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: 16498816
• Report Number: 1417592-2023-00090
• Device Sequence Number: 17755378
• Product Code: FMI
• UDI-Device Identifier: 10193489031973
• UDI-Public: 10193489031973
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 03/07/2023

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 Model Number: SSN100253
• Device Catalogue Number: SSN100253
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2023
• Initial Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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