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

Catalog Number	DYNJV0282K
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility "air (is) being introduced into their manifold".Per the facility "at the connection point on the pressure tubing, the luer lock is causing excessive air (to be) introduced into the system".Per the facility "small/minor air was injected into a patient without any harm occurring to the patient".Per the facility prior to injection the staff are needing to "flush manifold and retry" to prevent air from being injected into the patient.The customer did not report any serious injury, medical intervention, or follow up care related to the reported incident.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.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.
Event or Problem Description
According to the facility "air (is) being introduced into their manifold".
Additional Manufacturer Narrative
Update to h4: manufacturing date.Update to h6: investigation findings.Update to h6: investigation conclusions.

• Common Device Name: DBD-ANGIOGRAPHY DRAPE PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 22566909
• Report Number: 1423395-2025-00076
• Device Sequence Number: 3993891
• Product Code: OES
• UDI-Device Identifier: 10195327538965
• UDI-Public: 10195327538965
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Followup
• Report Date (Section B): 07/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJV0282K
• Device Lot Number: 23KMB043
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/02/2023
• 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