MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; HEART CATH PACK

Model Number	DYNJ61294D
Medical Device Problem Codes	Crack (1135); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that, according to a procedural tech, air leaked into a control syringe component.Reportedly, this has occurred "during drawback" and "when pushing plunger in halfway" and that air leaks from "the rear of the plunger." according to the reporting facility, they have also noticed "small cracks." 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.The reporting facility returned samples for review on 07-aug-2023 and 05-sep-2023.During testing, it was observed that the samples capture air when water is drawn into the syringe.The reported proble/issue was confirmed and the root cause was determined to be crushed red o-ring of the screw in the syringes.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, according to a procedural tech, air leaked into a control syringe component.

• Common Device Name: HEART CATH 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: 18978291
• Report Number: 1423395-2024-00204
• Device Sequence Number: 15110599
• Product Code: OEZ
• UDI-Device Identifier: 40193489305402
• UDI-Public: 40193489305402
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: DYNJ61294D
• Device Lot Number: 23FBE604
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2023
• 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