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

Catalog Number AS9232-57

Device Problem Detachment Of Device Component (1104)

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

Event Date 10/22/2017

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 surgeon reported the hydro-cannula detached from syringe while in use during 22 out of 45 cataract procedures on the same day.The procedures was performed and completed after replacing the product with another one.There was no harm to the patients.One product sample is available.No additional information is expected.

Manufacturer Narrative

The customer reported that the hydro-cannula occasionally detaches from the syringe while in use.This is the first complaint for the custom pak finish goods lot and the first complaint reported for this issue.A review of the device history records indicates the order was built to specification.A complaint history examination indicated there were no additional complaints associated with the lot for the reported issue.One syringe was returned and investigated by the supplier.The suppliers translated report is attached to the parent file.The returned sample had no defect such as a crack, deform, or foreign material attached on the point of the syringe which leads to a weaker connection.No loose connection or abnormality was confirmed.The sample was inspected using a gauge under jis (japanese industrial standards) specification.The sample was within the standard specification.The manufacturing inspection record was reviewed.The outer syringe was formed by inserting dissolved raw material resin with high-pressure into a formed gauge-outed metal mold.Next, it is cooled and tightened and manufactured consecutively.Sampling is completed per 8 hours on the size and the formation.In addition, one cannula was also received in a small parts tray and was found to be conforming.The sample was functionally tested for luer taper, fit with a syringe and air flow and was found conforming for all functional testing.The returned samples were found to be conforming; therefore, root cause of the customer's complaint could not be established as the sample met specifications.After a thorough investigation of this complaint, it has been determined that no action will be taken at this time as the returned sample met specifications.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: 7047812
• MDR Text Key: 93086718
• Report Number: 1644019-2017-00799
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2018
• Device Catalogue Number: AS9232-57
• Device Lot Number: 2042510H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2017
• 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