FDA Adverse Event Injury Summary report: N

CUSTOM PAK

MDR report key: 2901137 · Received January 4, 2013

Report

Report Number: 1644019-2012-00235
Event Type: Injury
Date Received: January 4, 2013
Manufacturer: ALCON - HOUSTON
Product Code: KYG
PMA / PMN Number: NA
Removal / Correction Number: NA
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OK, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

A SAMPLE HAS BEEN RECEIVED AND EVALUATION IS IN PROGRESS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

Description of Event or Problem · 1

A NURSING MANAGER REPORTED THAT DURING THE HYDRODISSECTION STEP OF A CATARACT WITH IOL (INTRAOCULAR LENS) IMPLANT PROCEDURE, THE SURGEON SQUEEZED THE SYRINGE, AND NOTHING CAME THROUGH THE TIP; AT THAT POINT, THE CANNULA CAME OFF THE SYRINGE AND PROJECTED INTO THE POSTERIOR CAPSULE. IT WAS THEN NECESSARY FOR THE SURGEON TO PERFORM AN ANTERIOR VITRECTOMY, AND THE IOL WAS ALBE TO BE INSERTED INTO PLACE. THE PATIENT WAS REPORTED TO BE DOING WELL. IT WAS NOTED THAT THE SCRUB NURSE FROM WHOM THE 30 GAUGE CANNULA WAS RECEIVED WAS SOMEWHAT INEXPERIENCED, AND WHEN THE SURGEON REQUESTED A NEW CANNULA, THE SCRUB NURSE MAY HAVE HANDED HIM A REUSED ONE, AS THERE HAVE BEEN REUSES OF THESE PRODUCTS AT THIS FACILITY. IN ADDITION, THE SURGEON WASN'T CERTAIN THAT THE SCRUB NURSE HAD PROPERLY TIGHTENED THE SYRINGE TO THE HYDRODISSECTOR CANNULA, AND DID NOT TEST THE SYRINGE TO MAKE SURE THAT FLUID WAS PASSING THROUGH.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
4822	CUSTOM PAK	CONVENIENCE KIT	KYG	ALCON - HOUSTON	CUSTOM PAK	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention	PROVISC CANNULA 27G 11 MM BEND