MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; SYRINGE,CONTROL,LL,FINGER,GRIPS,10ML

Model Number DYNJPOLYCON1

Device Problem Material Fragmentation (1261)

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

Event Date 07/07/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported that the thumb ring of the control syringe broke off.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 it was confirmed that the thumb ring had broken off of the syringe plunger.Visual inspection noted that the thumb ring broke due to a shear force being applied rather than an axial force.There was no indication of a short shot and the plunger was able to rotate within the barrel and slide axially with low resistance, indicating that no excessive force was required to operate the syringe.The root cause for the reported problem/issue was determined was determined to be customer misuse as a shear force was applied rather than an axial force.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.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that the thumb ring of the control syringe broke off.

• Type of Device: SYRINGE,CONTROL,LL,FINGER,GRIPS,10ML
• 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: 18865156
• MDR Text Key: 337200468
• Report Number: 1417592-2024-00344
• Device Sequence Number: 1
• Product Code: FMF
• 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: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DYNJPOLYCON1
• Device Lot Number: 6371900007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2021
• Date Manufacturer Received: 07/07/2021
• 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