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

Catalog Number 15376

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

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 physician reported observing a small blue fiber embedded in the incision after a procedure.This is one of two reports for this facility.(b)(4).

Manufacturer Narrative

No lot number was identified with this complaint; therefore, lot history and complaint history reviews could not be conducted.A sample has not been returned for this complaint therefore the condition of the product could not be verified.A review of the products bill of materials indicates a blue drape, blue paper towels, and blue gowns are assembled into this pack.When this type of issue occurs, a sample will need to be returned so that a full evaluation can be conducted.Without a sample, we were unable to demonstrate where the blue fiber associated with the event originated.With the available information we were unable to determine the origin of the reported blue fiber.Analysis of the sample could not be performed and no lot information is available, therefore, the root cause for the customer reported event could not be established.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.The root cause for this complaint is not known, therefore, specific action with regards to this complaint cannot be taken.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trends and take further action, as appropriate.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, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 8651265
• MDR Text Key: 146652183
• Report Number: 1644019-2019-00079
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 15376
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1