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

Model Number CUSTOM PAK

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2014

Event Type  malfunction  

Event Description

A certified surgical technician reported they have noticed that the luer lok portion of the 3cc syringes appeared to be crooked; therefore, the cannula goes on crooked and then leaks.No pt harm has been reported.No additional info is expected.

Manufacturer Narrative

A sample is expected but has not been received.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 info becomes available.(b)(4).

• Brand Name: CUSTOM PAK
• Type of Device: CONVENIENCE KIT
• Manufacturer (Section D): ALCON - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: janet moran ; 6201 south freeway, r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 3807600
• MDR Text Key: 4371863
• Report Number: 1644019-2014-00048
• Device Sequence Number: 1
• Product Code: KYG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Model Number: CUSTOM PAK
• Device Catalogue Number: CUSTOM PAK
• Device Lot Number: 1526602H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• 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