MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; PLASTIC SURGERY SERV-DR GARAZO

Model Number DYNJ34199A

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 06/13/2023

Event Type  malfunction  

Manufacturer Narrative

It was reported that the bulb syringe was not working correctly.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.Additional lot numbers reported = n/a.Additional serial numbers reported = n/a.

Event Description

It was reported that the bulb syringe was not working correctly.

• Type of Device: PLASTIC SURGERY SERV-DR GARAZO
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093 2753
• Manufacturer Contact: gabriella silva ; three lakes dr; northfield, IL 60093-2753
• MDR Report Key: 19085624
• MDR Text Key: 340686446
• Report Number: 1423395-2024-00303
• Device Sequence Number: 1
• Product Code: FTN
• UDI-Device Identifier: 40884389380407
• UDI-Public: 40884389380407
• 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: 04/10/2024

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 Model Number: DYNJ34199A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/13/2023
• Initial Date FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other