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

Model Number DYNJ0275124L

Device Problem Contamination (1120)

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

Event Date 02/26/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that unspecified "debris" was noted to be inside of a luer-lock 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.The syringe component involved in the incident was returned for evaluation.A small, brown flake of particulate was noted inside the barrel of the syringe, behind the plunger.The particulate was viewed under magnification and was found to be consistent with a piece of cardboard.The problem/issue was confirmed and issues with environmental controls was identified to be the cause.Due to the reported contamination within a fluid pathway, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that unspecified "debris" was noted to be inside of a luer-lock syringe component.

Manufacturer Narrative

Update made to d2 product information.

Event Description

It was reported that unspecified "debris" was noted to be inside of a luer-lock syringe component.

• Type of Device: DBD-OPHTHALMIC 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: 18730274
• MDR Text Key: 336756975
• Report Number: 1423395-2024-00020
• Device Sequence Number: 1
• Product Code: OJK
• 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: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DYNJ0275124L
• Device Lot Number: 19AKC126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Date Manufacturer Received: 02/26/2019
• 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