MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; 3ML SYRINGE IN DBD-PHACO EYE PACK

Catalog Number	DYNJ82650
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the cannula is "not secure to the syringe" and is causing detachment that led to the cannula "coming loose in the patient eye, breaks the bag, and results in an anterior vitrectomy".The customer reported this occurs when "irrigating the eye" with "bss" and the customer believes "the groove on the syringe is not adequate enough to provide a secure fit for the cannula".It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that the cannula is "not secure to the syringe" and is causing detachment that led to the cannula "coming loose in the patient eye, breaks the bag, and results in an anterior vitrectomy".
Event or Problem Description
It was reported that the cannula is "not secure to the syringe" and is causing detachment that led to the cannula "coming loose in the patient eye, breaks the bag, and results in an anterior vitrectomy".
Additional Manufacturer Narrative
Update made to d2 product information.

• Common Device Name: 3ML SYRINGE IN DBD-PHACO EYE PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 19038971
• Report Number: 1423395-2024-00293
• Device Sequence Number: 7354958
• Product Code: FMF
• UDI-Device Identifier: 40195327199235
• UDI-Public: 40195327199235
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ82650
• Device Lot Number: 22HBO903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown