MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; VASCULAR SPECIAL PROCEDURE PAC

Model Number DYNJ81194

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/19/2023

Event Type  malfunction  

Event Description

It was reported that a syringe broke while drawing up lidocaine and a physician experienced a hand injury.

Manufacturer Narrative

It was reported that a syringe broke while drawing up lidocaine and a physician experienced a hand injury.The reporting facility indicated that they physician required no follow up care and no serious injury was reported.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.A photo was provided for review and the plunger flange was noted to have broken completely off of the plunger.The plunger and barrel remained intact and no other defects were noted.No physical sample was returned for evaluation.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.

• Type of Device: VASCULAR SPECIAL PROCEDURE PAC
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 18881238
• MDR Text Key: 337688859
• Report Number: 1423395-2024-00322
• Device Sequence Number: 1
• Product Code: OEZ
• UDI-Device Identifier: 40195327091744
• UDI-Public: 40195327091744
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DYNJ81194
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other