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

Catalog Number 8065752918

Device Problem Inadequacy of Device Shape and/or Size (1583)

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

Event Date 12/07/2016

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 that the purple infusion sleeves are too big.The procedure was completed with the product without harm to the patient.No further details were available.A product sample was received at the manufacturing site and it is awaiting evaluation.

Manufacturer Narrative

The lot specific to this event is not known; therefore, lot history and device history record reviews are not possible.Two purple infusion sleeves were returned for this complaint.The samples were visually inspected and no abnormalities were observed.The texture on the inner wall of the shafts and tips of the infusion sleeves was intact.The inner diameter of both sleeves was found to be within specification.The irrigation flow rate was performed using a lab stock cassette, tip and hand piece.No drop presented from the hand piece after the irrigation was off for 5 seconds.The root cause of the customer's complaint could not be established as the returned infusion sleeves met specifications.After a thorough investigation of this complaint, it has been determined that the samples met specifications; therefore, no action will be taken at this time.Quality assurance will continue to monitor customer complaints via the complaint review meetings and will take action for any future occurrences as is deemed necessary.(b)(4).

Event Description

A customer reported feels that the purple infusion sleeves are too big.The procedure was completed with the product without harm to the patient.No further details were available.A product sample was received at the manufacturing site and it is awaiting evaluation.

• Brand Name: CENTURION SURGICAL PROCEDURE PAK
• 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: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 6277211
• MDR Text Key: 66037479
• Report Number: 1644019-2017-00079
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065752918
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2017
• 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 Outcome(s): Other