MAUDE Adverse Event Report: AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD. DAKO OMNIS BUFFER/SOLVENT CONTAINER

Model Number GC109

Device Problems Fluid/Blood Leak (1250); Use of Device Problem (1670)

Event Date 06/26/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation is currently ongoing.No additional information has been made available.Therefore, this report is being filed as part of agilent's commitment to due diligence reporting.H4: date of manufacturing is unknown as product is manufactured by third party company, unable to retrieve date.

Event Description

Customer was preparing to run a maintenance task "clean liquid system".Bulk bottles with 0,1m sodium hydroxide (naoh) had been prepared up front and were stored on the top shelf of a chemicals-cabinet.When taking 2 bulk bottles out of the cabinet, the liquid splashed inside the bottles.Due to a defective cap, the liquid splashed out of the bottle and onto the user, hitting her in the face and neck area.Some liquid got into her eyes.The lab staff reacted immediately using the safety equipment in the lab to rinse out any naoh from skin and eyes.The lab technician was brought to hospital and examined for eye-damage.The lab technician was back at work 4-5 days after the incident.The lab technician still experiences a bit of irritation in the eye, but no long-term effect is expected by her doctor.Factors contributing to the incident are the following: 1.The ventilation valve had fallen out and into the bottle.It is still unknown the reason of the ventilation valve being defective.2.The bottles were placed on the top shelf, so the user could not see that the cap was defective 3.The user was not wearing protective glasses as instructed in the basic user guide.Chemicals cabinet has been re-arranged and the lab was informed that the user guide instructs users to wear protective glasses during maintenance with naoh.

Event Description

Additional information was received confirming the issue to be user error.After investigation it was determined that the end user accidentally put an unknown solvent (possibly xylene, from smell) into the dedicated bulk bottle used for clean liquid system (cls) which should normally be 0.1 m naoh.Every time the customer performed the cls cleaning task an amount of this solvent was flushed through the instrument and ended up in the waste bulk bottles.The waste caps therefore were affected by the vapors inside the bulk bottle causing the loose plug issue.As the caps moved around between bottles after cleaning of instrument bulk bottles the problem was observed in many different positions.Application specialist disposed of the naoh containers including their contents and made the maintenance of liquid system with fresh naoh.All caps have been replaced and labeled according to the protocol.

• Brand Name: DAKO OMNIS BUFFER/SOLVENT CONTAINER
• Type of Device: DAKO OMNIS BUFFER/SOLVENT CONTAINER
• Manufacturer (Section D): AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD.; no.1 yishun avenue 7; singapore, 76892 3; SN 768923
• Manufacturer (Section G): FISCHER SÖHNE AG; luzernerstrasse 105; muri, 5630 ; SZ 5630
• Manufacturer Contact: mary o'neill ; 1834 state highway 71 west; cedar creek, TX 78612 ; 3026338510
• MDR Report Key: 17388919
• MDR Text Key: 319955829
• Report Number: 3003423869-2023-00086
• Device Sequence Number: 1
• Product Code: KPA
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GC109
• Device Catalogue Number: GC10930
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female