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

Model Number CUSTOM PAK

Device Problems Fitting Problem (2183); Device Issue (2379); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2014

Event Type  malfunction  

Event Description

A healthcare professional reported a syringe issue as they are difficult to handle.The cannula is not fitting snugly and is crooked on the tip of the syringe.The reported informed that this is causing a decrease in visibility during procedures.

Manufacturer Narrative

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).

• Brand Name: CUSTOM PAK
• Type of Device: CONVENIENCE KIT
• Manufacturer (Section D): ALCON HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON MANUFACTURING, LTD.; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: janet morqn ; 6201 south freeway. r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 3902756
• MDR Text Key: 4428146
• Report Number: 1644019-2014-00018
• 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: 01/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CUSTOM PAK
• Device Catalogue Number: CUSTOM PAK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/14/2014
• Initial Date FDA Received: 02/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: CANNULA