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

Catalog Number 14686

Device Problem Insufficient Information (3190)

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 customer reported issue with the "pink side port knife", three nurses have injured themselves when removing the knife from the plastic holder.Upon follow up it was informed that "the type of injury experienced is a clean poke, occurring prior to contact with the patient, when opening the instrument's packaging." there was no medical intervention indicated.

Manufacturer Narrative

A product sample has been received at the manufacturing site and it is awaiting evaluation.(b)(4).

Manufacturer Narrative

There have been no additional complaints reported against the finish goods lot and the device history record review shows that the product was released per specifications.The customer returned four sealed straight 15 degree pink knives in pouches.The root cause of the customer¿s complaint is related to the way the knives are being packaged which would be a supplier related issue.The supplier has been made aware of the issue and the sample has been sent to the supplier for their internal investigation; however, as the occurrence rate for this failure is low and this appears to be an isolated incident, no formal root cause or corrective action has been requested.Quality assurance will continue to monitor and will take action for future occurrences as deemed necessary.An internal investigation has been opened to address reports of a similar nature.(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: 6571785
• MDR Text Key: 75326458
• Report Number: 1644019-2017-00423
• Device Sequence Number: 0
• Product Code: OJK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 14686
• Device Lot Number: 1966378H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2016
• 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