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

Catalog Number 12757

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Type  Injury  

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 a patient presented with a fiber in the incision during a postoperative visit.The fiber was removed with a forcep and the patient experienced a mild wound leak.The current status of the patient was not indicated.Additional information was requested, however, the reporter indicated she was unable to provide additional information.This is one of three reports for this surgeon.

Manufacturer Narrative

As the customer did not retain the finished goods lot number, device history record (dhr) and lot history could not be reviewed.A sample has not been returned for this complaint.When this type of issue occurs, a sample will need to be returned so that a proper investigation can be conducted.If possible, at the very least, the customer should provide the manufacturer with a photo of the fiber to assist with the investigation of the issue.If a sample is returned at a later date, the investigation will be reopened and the sample evaluated.The root cause of the customer's complaint could not be established as a sample has not been received.Without a sample, it is not possible to isolate the root cause.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.Action will not be taken for this occurrence.Quality assurance will continue to monitor and take action for any future occurrences as is deemed necessary.Manufacturing management and quality engineering materials will be made aware of this complaint through the monthly complaint review meeting.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The lot complaint history was reviewed.This is the first complaint for the finished goods lot; also, it is the first complaint for this issue for this lot.The device history record shows the product was released per specifications.A specimen cup was returned and visually inspected.Various debris were found on a folded piece of scotch tape inside the specimen cup.The debris was examined microscopically, and a dark blue, natural appearing fiber was observed.The fiber was isolated and analyzed using microscopic fourier transform infrared spectroscopy (micro ft-ir) and the closest match was found to be cotton.While the customer¿s complaint was confirmed, the definitive root cause of the cotton found inside of the pack 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.In addition, measures are in place to ensure that the proper procedures are followed when packaging custom paks.These procedures include, but are not limited to a clean work surface, storing product properly and ensuring components are correct.Action will not be taken for this occurrence.It is recommended that the customer place the surgical instruments on a mayo tray and if applicable avoid placing them directly on a mayo stand cover or the back table cover.Additionally, the instruments should be wiped before passing back to the surgeon.This will assist in preventing lint contamination on instruments and help to reduce the risk of lint getting into the patience eye.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

A product sample has been received by the manufacturer and it is awaiting evaluation.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: 8111720
• MDR Text Key: 128633062
• Report Number: 1644019-2018-00274
• 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: health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2021
• Device Catalogue Number: 12757
• Device Lot Number: 2217906H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Date Manufacturer Received: 07/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention