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

Catalog Number 8065751902

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2019

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.The manufacturer internal reference number is: (b)(4).

Event Description

A biomedical engineer reported that the infusion cannula disconnected from the tubing during a procedure.The product was replaced and the procedure was completed.There was no patient harm.

Manufacturer Narrative

The lot complaint history was reviewed, this is the fifth complaint for the finish goods lot; however, the first for this issue for this lot.The device history record shows the product was released per specifications.The returned infusion cannula assembly was visually inspected and the infusion cannula tip was detached from tubing.Microscopic examination at the end of the silicone tubing indicated the cannula tip was likely mounted onto the tubing at one point.There was a slight swell and stretch marks in the tubing.A review of the assembly procedure demonstrated after assembly of the silicone tubing to the infusion cannula a 100% visual inspection is performed.The root cause of the customer's complaint could not be determined conclusively.The investigation could not determine how or where the detachment of the cannula occurred.Action will not be taken based on this occurrence.An analysis of similar complaints of infusion cannula detachment confirmed no unfavorable trend for this event.This issue is occurring at a very low level.Quality assurance will continue to monitor and will take action for future occurrences as is deemed necessary.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION SURGICAL PROCEDURE PAK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 8836424
• MDR Text Key: 152531135
• Report Number: 1644019-2019-00118
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 8065751902
• Device Lot Number: 2157946H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Date Manufacturer Received: 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR