MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DBD-PHACO EYE PACK

Catalog Number DYNJ82650

Device Problem Connection Problem (2900)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/12/2023

Event Type  Injury  

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 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".

• Type of Device: DBD-PHACO EYE PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093 2753
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 19038971
• MDR Text Key: 339319765
• Report Number: 1423395-2024-00293
• Device Sequence Number: 1
• Product Code: OJK
• UDI-Device Identifier: 40195327199235
• UDI-Public: 40195327199235
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 01/12/2023
• 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