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

Catalog Number 15409-08

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Retinal Tear (2050); Vitreous Hemorrhage (2143)

Event Date 02/05/2024

Event Type  Injury  

Event Description

A non healthcare professional reported that the cannula pop off the syringe during surgery.No information was provided on completion of surgery.The procedure type was unknown.There was no report of patient harm.Additional information received from the non healthcare professional that the patient experienced vitreous hemorrhage, horseshoe retinal tear.The patient underwent anterior vitrectomy and retina surgery with silicone oil as a result of this harm.

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).

Manufacturer Narrative

A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.The customer reported a cannula popped off a luer lock syringe.The cannula reported to be used was viscoflow - irrigation cannula.A review of the bill of material for the reported finished goods this lot indicated this cannula was not part of this custom pak.Therefore the cannula that was used was not part of the surgical custom pak provided to this customer.Additionally, no sample was returned for evaluation.The root cause of the customer's complaint could not be conclusively determined as a sample was not received and the condition of the product could not be verified.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.The investigation did find the cannula was not part of the surgical custom pak finished goods lot.The root cause for this complaint is not known, therefore, specific action with regards to this complaint cannot be taken.Current tracking indicates no adverse trend for this lot for this event.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending 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
• Manufacturer (Section G): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 18863742
• MDR Text Key: 337179555
• Report Number: 1644019-2024-00419
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 15409-08
• Device Lot Number: JZ5199515
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/13/2024
• Initial Date FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female