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

Model Number DYNJ58896D

Device Problem Contamination (1120)

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

Event Date 12/30/2020

Event Type  malfunction  

Event Description

It was reported that a "white fleck" was noted within a bulb irrigation syringe component.

Manufacturer Narrative

It was reported that a "white fleck" was noted within a bulb irrigation syringe component.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 two (2) small cosmetic white marks less than 1mm in diameter were noted on the barrel of the bulb irrigation syringe about its tip.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.

• Type of Device: DBD-GENERAL PLASTIC PACK-LF
• 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: 18984458
• MDR Text Key: 339210820
• Report Number: 1423395-2024-00212
• Device Sequence Number: 1
• Product Code: FTN
• 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: DYNJ58896D
• Device Lot Number: 20JBQ157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Initial Date Manufacturer Received: 12/30/2020
• 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