MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; CATH LAB PACK

Catalog Number	DYNJ54019D
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the facility on (b)(6), "the syringe was connected to the back end of the manifold while flushing the manifold and attached to the patient the syringe started to back itself off or unscrew itself allowing air to end the manifold.".
Additional Manufacturer Narrative
According to the facility on (b)(6), "the syringe was connected to the back end of the manifold while flushing the manifold and attached to the patient the syringe started to back itself off or unscrew itself allowing air to end the manifold".There are no visible cracks and deformities to the syringe.The procedure being performed was a left heart cath and this occurred in the middle of the procedure.The facility stated there was no serious injury or impact to the patient and that there were no complications.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: CATH LAB PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 20758785
• Report Number: 1423395-2024-00501
• Device Sequence Number: 8393242
• Product Code: OES
• UDI-Device Identifier: 40193489457828
• UDI-Public: 40193489457828
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/22/2024

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: DYNJ54019D
• Device Lot Number: 24IMD318
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 11/22/2024
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown