MAUDE Adverse Event Report: CARDINAL HEALTH MAGELLAN 3ML SFTY COMBO 21X1; SYRINGE, PISTON

Model Number 8881833110

Device Problem Use of Device Problem (1670)

Patient Problem Eye Injury (1845)

Event Type  Injury  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reported that there was a cataract extraction was performed on (b)(6) 2023, followed by implant of the lens as scheduled.After the implant of the lens, the surgeon was given a 3ml syringe filled with 3ml of bss (balanced salt solution) with a hydrodissection needle attached.The surgeon inserted the needle to the incision and it was then noted that the fluid came out of the eye quickly and the syringe was visualized by an associate to be in the surgeon's hand without the needle attached to the syringe, but was still located in the incision.The surgeon then viewed the needle through the microscope and removed it.The surgeon informed the surgical team that the lens would need to be removed and a vitrectomy would need to be performed.The patient suffered a complication due to the cannula shooting off into the eye while hydrating paracentesis at the end of the case.The cannula damaged capsule and zonules, causing iol(intraocular lens)/bag complex to dislocate.The iol implant was cut out of the eye and an anterior vitrectomy was performed.The patient was left aphakic.The initial investigation following this event determined that the event was due to user error.However on (b)(6) 2023, the physician suggested that the event may have been caused by an equipment malfunction.Per additional information received, the needle and the hub detached together from the syringe.The cardinal needle was removed from the cardinal syringe.The physician/health professional replaced the cardinal needle with an alton hydrodissection needle and used it combination with the cardinal syringe.This was the needle that was used multiple times throughout the procedure.

• Brand Name: MAGELLAN 3ML SFTY COMBO 21X1
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 2010 east international speedw; deland FL 32724
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 17575795
• MDR Text Key: 321462471
• Report Number: 1017768-2023-01088
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10192253024692
• UDI-Public: 10192253024692
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 8881833110
• Device Catalogue Number: 8881833110
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1