MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; DBD-ULLMAN EYE PACK

Model Number DYNJ37739L

Device Problem Material Integrity Problem (2978)

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

Event Date 05/01/2023

Event Type  malfunction  

Event Description

It was reported that the flange on the syringe is breaking very easily, and this one in particular it looks like part has melted.

Manufacturer Narrative

It was reported that the flange on the syringe is breaking very easily, and this one in particular it looks like part has melted.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 (b)(4) 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.

• Type of Device: DBD-ULLMAN EYE PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: brandon kroeger ; three lakes dr; northfield, IL 60093-2753
• MDR Report Key: 19061818
• MDR Text Key: 340459883
• Report Number: 1423395-2024-00258
• Device Sequence Number: 1
• Product Code: OJK
• 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: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DYNJ37739L
• Device Lot Number: 23CBD173
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other