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

Catalog Number 0935

Device Problem Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/13/2017

Event Type  malfunction  

Manufacturer Narrative

A product sample was received and it is awaiting evaluation.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 doctor reported that two blades had a slight burr on the end.The procedure was completed without consequences to the patient.Additional information has been requested and received.

Manufacturer Narrative

This is the first complaint reported for this finished goods lot.Review of the device history record (dhr) indicates the order was built to specification.Review of the dhr found a temporary deviation to add the blade as a substitution.One sample was received for evaluation.Though the definitive root cause could not be determined in the lab, the most likely root cause of the customer's complaint is an error that occurred during the supplier's manufacturing process.The root cause of the customer¿s dissatisfaction with the knife substitution is due to a temporary deviation which occurred due to a backorder with the supplier.During the backorder, a substitute knife was approved for use.Quality engineering materials has notified the supplier and sent the sample for further investigation.The supplier has sent an email acknowledgement in receipt of complaint issue.Quality assurance will continue to monitor and take action for any future occurrences as is deemed necessary.Quality engineering materials will be notified of this complaint through the monthly complaint review meeting.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: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 6454988
• MDR Text Key: 71708574
• Report Number: 1644019-2017-00309
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2019
• Device Catalogue Number: 0935
• Device Lot Number: 1947252H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/04/2016
• 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