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

Model Number CUSTOM PAK

Device Problems Bent (1059); Improper or Incorrect Procedure or Method (2017)

Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)

Event Date 02/24/2014

Event Type  malfunction  

Manufacturer Narrative

There is no additional information available for this report.A sample of the product used was received and it is awaiting evaluation.Investigation, including root cause analysis, is in progress.A supplemental mdr will be field as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(4).

Event Description

A nurse reported that a surgical technician got stuck with a used 30 gauge needle, left hand, middle finger, when assisting in an eye surgical procedure.The reporter informed that the incident occurred when the surgical technician went to re cap the needle with the cap.The needle bent and pierced through the side of the cap.The patient in which the needle was used was sent for blood testing.The lab results were fine as per the reporter.The technician was not sent for blood testing as the patient's blood test were fine.There is no additional information available for this report.A sample of the product used was received and it awaiting evaluation.

• 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: 3879658
• MDR Text Key: 16586617
• Report Number: 1644019-2014-00062
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2014
• 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?: Yes
• Date Returned to Manufacturer: 03/14/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2014
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 23 YR