MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DBD-PLASTIC PACK E7SUR

Model Number DYNJ81855A

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/08/2023

Event Type  malfunction  

Manufacturer Narrative

It was reported that the middle loop of the control syringe component "came apart" during use.The reporting facility also indicated that "when pressure is applied it slips out of place." 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 functional testing confirmed that the both the plunger and the syringe plastic holders were easily detachable.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 middle loop of the control syringe component "came apart" during use.

• Type of Device: DBD-PLASTIC PACK E7SUR
• 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: 19056747
• MDR Text Key: 340459925
• Report Number: 1423395-2024-00305
• Device Sequence Number: 1
• Product Code: FTN
• UDI-Device Identifier: 40195327302994
• UDI-Public: 40195327302994
• 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: 04/06/2024

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: DYNJ81855A
• Device Lot Number: 23GMI460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2023
• Initial Date Manufacturer Received: 11/08/2023
• Initial Date FDA Received: 04/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other