MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HOUSTON CUSTOM-PAK SURGICAL PROCEDURE PACK; GENERAL SURGERY TRAY (KIT)

Catalog Number 14178

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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).

Event Description

A nurse reported the surgeon observed a fibers in his visual field and in the eye during a procedure.Additional information was requested; however, none has been received to date.This is one of two reports for this facility.

Manufacturer Narrative

Additional information provided.There have been no additional complaints reported against the finished goods lot and the device history record shows the product was released per specifications.The customer reported that they observed fibers in the visual field and in the eye.The scrubs also noticed fibers when rubbing their gloved hands across the back table cover.The customer did not retain a sample for this complaint report; visual inspection or particulate testing could not be conducted.Without a sample or photo, the root cause cannot be determined.Possible root cause include an error in the warehouse, an error made during the custom pak internal manufacturing process and an error made during the supplier¿s manufacturing process.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.Warehouse operations states that product shall be stored in containers that are closed to the warehouse environment in order to prevent mix-ups and to prevent product from being coated with dust or otherwise soiled.Action will not be taken for this occurrence.The account manager is working with the sales administration to change the mayo cover in the customer¿s pak.The manufacturer internal reference number is: (b)(4).

• Brand Name: CUSTOM-PAK SURGICAL PROCEDURE PACK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7333268
• MDR Text Key: 102333128
• Report Number: 1644019-2018-00049
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2020
• Device Catalogue Number: 14178
• Device Lot Number: 2114065H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2018
• 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 Outcome(s): Other