MAUDE Adverse Event Report: ALCON MANUFA-HOUSTON CUSTOM PAK; CONVENIENCE KIT

Model Number CUSTOM PAK

Device Problems Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2015

Event Type  malfunction  

Event Description

A surgeon reported that during a combined cataract and vitrectomy surgery, the infusion cannula failed to lock into the trocar.After everything had been set up and the cassette had been primed, the surgeon started the surgery by placing the trocar into the eye and then placed the infusion cannula into the trocar.As soon as the infusion pressure was turned on, the infusion cannula popped out of th e trocar.A new pak was opened and this time the infusion cannula locked with the trocar and surgery could be completed.This is one of five mdr being filed for this facility.

Manufacturer Narrative

A sample has been rec'd at mfg site.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when add'l reportable info becomes available.(b)(4).

• Brand Name: CUSTOM PAK
• Type of Device: CONVENIENCE KIT
• Manufacturer (Section D): ALCON MANUFA-HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: janet moran ; 6201 s freeway; r3-48; fort worth, TX 46134 ; 8176152742
• MDR Report Key: 4551479
• MDR Text Key: 17697608
• Report Number: 1644019-2015-00018
• Device Sequence Number: 1
• Product Code: KYG
• Combination Product (y/n): N
• Reporter Country Code: CY
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Model Number: CUSTOM PAK
• Device Catalogue Number: CUSTOM PAK
• Device Lot Number: 1659069H
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/19/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CONSTELATION TABLETOP; 23GA TOTAL PLUS COMBINED PROCEDURE PAK; ASSY, SNTR, VALVED ENT
• Patient Age: 76 YR