MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DBD-VAGINAL DELIVERY

Model Number DYNJ62441

Device Problem Mechanical Problem (1384)

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

Event Date 01/28/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported that an ear ulcer syringe component was difficult to squeeze.The reporting facility indicated that it was "almost like the material is thicker with not much give than usual." no serious injury or adverse impact to a patient or a user was originally 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.No photo or physical sample was provided for evaluation and a definitive root cause was unable to be determined.In an abundance of caution, and in response to an fda 483 issued for cfn 1417592 on (b)(6) 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 an ear ulcer syringe component was difficult to squeeze.

• Type of Device: DBD-VAGINAL DELIVERY
• 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: 18999938
• MDR Text Key: 339129016
• Report Number: 1423395-2024-00240
• Device Sequence Number: 1
• Product Code: MLS
• UDI-Device Identifier: 40193489253543
• UDI-Public: 40193489253543
• 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: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DYNJ62441
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2021
• 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