MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; 35ML ORAL SYRINGE, CLEAR,STERILE

Model Number NON65135

Device Problem Contamination (1120)

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

Event Date 10/01/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported that foreign particulate was noted within oral syringes.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 photo was provided for review and foreign particulate within the barrel was confirmed.No physical sample was returned for evaluation, however, and a root cause was unable to be determined.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.Additional product lot reported = 210321.

Event Description

It was reported that foreign particulate was noted within oral syringes.

• Type of Device: 35ML ORAL SYRINGE, CLEAR,STERILE
• 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: 18951574
• MDR Text Key: 338262323
• Report Number: 1417592-2024-00277
• Device Sequence Number: 1
• Product Code: KYX
• 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: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: NON65135
• Device Lot Number: 210317
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2021
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other