MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; ARTERIOGRAM PACK

Model Number	DYNJ26878N
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the white wing finger holds are kit secured to the syringe and slide down the syringe into surgical field posing a serious patient safety risk.
Additional Manufacturer Narrative
It was reported that the white wing finger holds are kit secured to the syringe and slide down the syringe into surgical field posing a serious patient safety risk.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.

• Common Device Name: ARTERIOGRAM PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: jeffrey de torres ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 19082359
• Report Number: 1423395-2024-00248
• Device Sequence Number: 7628841
• Product Code: OES
• UDI-Device Identifier: 40193489244527
• UDI-Public: 40193489244527
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/09/2024

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 Model Number: DYNJ26878N
• Device Lot Number: 23ABL108
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown