MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; ANGIOGRAPHY FOAKS

Catalog Number DYNJ63573

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 03/21/2024

Event Type  malfunction  

Manufacturer Narrative

It was reported that particulate was found "inside" the syringe prior to use on the patient.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.

Event Description

It was reported that particulate was found "inside" the syringe prior to use on the patient.

Manufacturer Narrative

Incorrect information provided regarding a syringe component within dynj63573.The reported particulate found within a syringe fluid pathway occurred with a syringe component within product dynj63576a and was reported under medwatch report #1423395-2024-00395.There was no reported issue with a syringe within product dynj63573.Please refer to medwatch report #1423395-2024-00395 for details regarding the reported incident.

• Type of Device: ANGIOGRAPHY FOAKS
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes dr; northfield, IL 60093
• MDR Report Key: 19113381
• MDR Text Key: 340907745
• Report Number: 1423395-2024-00394
• Device Sequence Number: 1
• Product Code: OJG
• 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: 04/25/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ63573
• Device Lot Number: 23KBK058
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/15/2024
• Supplement Dates Manufacturer Received: 03/22/2024
• Supplement Dates FDA Received: 04/25/2024
• 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
• Patient Outcome(s): Other