MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; SYRINGE, LUER LOCK, STERILE, 10ML

Model Number SYR110010

Device Problem Contamination (1120)

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

Event Date 02/17/2023

Event Type  malfunction  

Manufacturer Narrative

It was reported that foreign particulate was noted within the syringe.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 reported problem/issue was confirmed with a small piece of plastic noted within the sample.The sample was in used condition with packaging opened.A root cause was unable to be determined as due to the condition of the sample, it could not be confirmed whether or not the foreign particulate was already inside of the syringe barrel upon receiving the unopened product or if it occurred while the sample was in use.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.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that foreign particulate was noted within the syringe.

• Type of Device: SYRINGE, LUER LOCK, STERILE, 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: 18966554
• MDR Text Key: 338494333
• Report Number: 1417592-2024-00210
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 40080196310198
• UDI-Public: 40080196310198
• 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: 03/24/2024

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: SYR110010
• Device Lot Number: 23ABG546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2023
• Initial Date Manufacturer Received: 02/17/2023
• Initial Date FDA Received: 03/24/2024
• 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