MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; I.R. PACK

Model Number DYNJ60343C

Device Problem Material Integrity Problem (2978)

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

Event Date 05/08/2023

Event Type  malfunction  

Manufacturer Narrative

It was reported that the handles on the syringe do not stay on.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 the handles on the syringe do not stay on.

• Type of Device: I.R. 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: 19072047
• MDR Text Key: 340578161
• Report Number: 1423395-2024-00263
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 40195327285044
• UDI-Public: 40195327285044
• 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: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DYNJ60343C
• Device Lot Number: 23CBL668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2023
• Date Manufacturer Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other