MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; NEURO ANGIO PACK

Catalog Number	DYNJ66652F
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	03/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the customer, on multiple occasions the line was "loose" when they attached it and caused "contrast" to be "wasted".The customer reported additional doses were required as a result of the reported incident.The customer reported there was no serious injury, medical intervention, or follow up care required as a result of the reported incident.Sample not available for return evaluation.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.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 customer, on multiple occasions the line was "loose" when they attached it and caused "contrast" to be "wasted".
Additional Manufacturer Narrative
Update b4 (originally put "date of this report as (b)(6) 2024 when it should have been (b)(6) 2024).

• Common Device Name: NEURO ANGIO PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093
• MDR Report Key: 19040110
• Report Number: 1423395-2024-00381
• Device Sequence Number: 20671162
• Product Code: OJG
• UDI-Device Identifier: 40195327467372
• UDI-Public: 40195327467372
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 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: DYNJ66652F
• Device Lot Number: 23LMC041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2024
• Supplement Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement 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