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

Catalog Number	DYNJ69094B
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the facility on (b)(6) 2024 "the manifold was being used to inject contrast into the coronary arteries of the patient".Per the facility "the syringe slipped off of the manifold on its own and was reattached".
Additional Manufacturer Narrative
According to the facility on 03/12/24 "the manifold was being used to inject contrast into the coronary arteries of the patient".Per the facility "the syringe slipped off of the manifold on its own and was reattached".Per the facility "the syringe stayed on for a couple of injections and then popped off again this time during an injection and contrast sprayed all over the physician and myself".Per the facility there was no impact to the patient and a different syringe was used.No additional information is available at this time.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.

• Common Device Name: CATH LAB PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 19047279
• Report Number: 1423395-2024-00389
• Device Sequence Number: 8483267
• Product Code: OES
• UDI-Device Identifier: 10193489372120
• UDI-Public: 10193489372120
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/04/2024

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: DYNJ69094B
• Device Lot Number: 24ABQ402
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 04/04/2024
• 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