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

Catalog Number 13471-06

Device Problem Fluid/Blood Leak (1250)

Patient Problems Vitreous Hemorrhage (2143); Excessive Tear Production (2235)

Event Date 01/05/2023

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.The manufacturer internal reference number is: (b)(4).

Event Description

A non-health care person reported 30g needle leaking at the hub and also popping off when being used on a patient which led to puncture to globe, small retinal hemorrhage per retina that did not require further intervention.

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.No physical sample has been returned for evaluation, therefore, the condition of the product could not be verified.When this type of issue occurs, a sample will need to be returned for examination of the product involved as it may provide clarification as to the cause for the reported failure.If possible, the customer should provide with a photo of the reported issue in order to help with the investigation of this complaint.A review of the reported pak's bill of materials (bom) shows the suspect product is bd5128- needle,30gx1.The root cause of the customer's complaint could not be established as a sample has not been received and the condition of the product could not be verified.Without analysis of the sample, it is not possible to isolate the root cause.Quality engineering materials has notified the supplier of this complaint issue per procedure.The supplier has acknowledged the complaint and concluded the root cause for this complaint is not known, therefore, specific action with regards to this complaint cannot be taken.Based on current tracking, there are no adverse trends for this reported complaint.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: 16350309
• MDR Text Key: 309261378
• Report Number: 1644019-2023-00137
• 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,Followup
• Report Date: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 13471-06
• Device Lot Number: 156FJF
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR