MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DBD-MAJOR PLASTIC PACK

Model Number DYNJ52759F

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 07/11/2023

Event Type  malfunction  

Manufacturer Narrative

It was reported that a control syringe component was "loose/flimsy" and that it did not "feel secure." 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.A sample was returned for evaluation and the finger handles on the control syringe were found to be flimsy, loose, and not secure.In an abundance of caution, and in response to an fda 483 issued for cfn (b)(4) 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 a control syringe component was "loose/flimsy" and that it did not "feel secure.".

• Type of Device: DBD-MAJOR PLASTIC PACK
• 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: 18978510
• MDR Text Key: 338597260
• Report Number: 1423395-2024-00196
• Device Sequence Number: 1
• Product Code: FTN
• UDI-Device Identifier: 40193489929486
• UDI-Public: 40193489929486
• 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: 03/26/2024

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: DYNJ52759F
• Device Lot Number: 23DBH191
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/11/2023
• Initial Date FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other