MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DBD-ANGIO PACK

Model Number	DYNJ50615C
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the syringe components in the pack "seem to explode or come apart during procedures." reportedly, this has occurred when the component has been used as a contrast syringe.No serious injury or adverse impact to a patient or a user was originally reported.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.Two (2) used samples were returned for evaluation.In both samples, the plungers were removed with one (1) plunger noted to have the black rubber stopper detached and in the barrel of a syringe.No damage or defects were noted with the second syringe and plunger.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.
Event or Problem Description
It was reported that the syringe components in the pack "seem to explode or come apart during procedures.".

• Common Device Name: DBD-ANGIO PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 18977556
• Report Number: 1423395-2024-00193
• Device Sequence Number: 20499626
• Product Code: OES
• UDI-Device Identifier: 40195327323180
• UDI-Public: 40195327323180
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/26/2024

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: DYNJ50615C
• Device Lot Number: 23CBG354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 03/26/2024
• 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