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

Catalog Number DYNJ66652F

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/07/2024

Event Type  malfunction  

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 Description

According to the customer, on multiple occasions the line was "loose" when they attached it and caused "contrast" to be "wasted".

Manufacturer Narrative

Update b4 (originally put "date of this report as (b)(6) 2024 when it should have been (b)(6) 2024).

• Type of Device: 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
• MDR Text Key: 339329510
• Report Number: 1423395-2024-00381
• Device Sequence Number: 1
• Product Code: OJG
• UDI-Device Identifier: 40195327467372
• UDI-Public: 40195327467372
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 04/04/2024
• Supplement Dates Manufacturer Received: 03/07/2024
• Supplement Dates FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1