FDA Adverse Event Injury Summary report: N

1222074-2018-00243

MDR report key: 8197206 · Received December 26, 2018

Report

Report Number: 1222074-2018-00243
Event Type: Injury
Date Received: December 26, 2018
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NL
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

SINCE THE CONCERNED PRODUCT WAS NOT RETURNED TO DORC, NO PHYSICAL EXAMINATION COULD BE PERFORMED TO CONFIRM THE ALLEGED FAILURE OR TO DETERMINE ITS CAUSE. IT IS POSSIBLE THAT OBSTRUCTION OF THE STANDARD INFUSION LINE OCCURS WHEN THE TIP IS INSERTED INTO THE CANNULA IN AN OBLIQUE ANGLE AND THE CLOSURE VALVE GETS (PARTIALLY) TRAPPED BETWEEN THE CAPILLARY OF THE TIP AND THE CANNULA ITSELF. A PIECE OF CLOSURE VALVE THAT GETS PUNCHED OUT DURING INSERTION OF THE INFUSION LINE OBSTRUCTS THE INFUSION LINE AND CAN RESULT IN COMPROMISED IRRIGATION. IT SHOULD BE NOTED THAT THE PROPER WAY TO INSERT THE INFUSION LINE IS DEPICTED IN THE USER INSTRUCTIONS PROVIDED WITH THIS PRODUCT. OTHER POTENTIAL CAUSES OF BLOCKAGE ARE POSSIBLE, FOR EXAMPLE IF THE INFUSION LINE BECOMES TRAPPED OR KINKED BY MANIPULATION DURING SURGERY. WITHOUT RETURN OF THE PRODUCT IS NOT POSSIBLE TO DETERMINE ROOT CAUSE WITH ANY CERTAINTY. [(B)(4)].

Description of Event or Problem · 1

INTRAOCULAR INFUSION BLOCKAGE DURING A 25G VITRECTOMY. SUDDEN HYPOTOMY OF THE EYE DURING SURGERY.

Patients

Seq	Age	Sex	Outcome	Treatment
1