MAUDE Adverse Event Report: FRESENIUS KABI DEUTSCHLAND GMBH K-ZERO NEEDLELESS CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number M79400849Y

Device Problem Infusion or Flow Problem (2964)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/24/2024

Event Type  Injury  

Manufacturer Narrative

Attempted to submit via fda esg on 24feb2024, but received the message "secure connection failed" on multiple web browsers.

Event Description

Per customer: "in the morning, wife wanted to disconnect food, disconnected infusion tube and could not screw saline syringe onto the k-zero.Blood then flowed back out of the port system.K-zero did not close by itself.Patient collapsed and emergency doctor was called.".1.Reported complaint: unknown connection problems.2.Quantity of sample(s): no sample or photo.3.Concerned product code / batch: k-zero needleless connector, m79400849y / batch 32335163.4.Investigation report: due to the fact that there was no sample or photo provided we are not able to confirm if the failure is related to the production process or material fault.We have visually inspected all retain samples and found no defect.In the next step, we performed a free flow and tightness test on one sample and the results were correct.Additionally, we performed a practical test using a syringe with water and found no abnormalities.Batch documentation review was performed and following data was checked: production orders, in process control and final inspection results, compliance with device master record, related nonconformities.Result: we did not find any deviations related to the complaint reason within the batch documentation.In the last 12 months (from 13.02.2023 to 12.02.2024) we have received 2 complaints for this article m79400849y with the same reason as " unknown connection problems".This is the first complaint for this batch 32335163 until now.5.Root cause.Not determined, as no defects have been found during investigation performed on the retain sample, further no irregularities detected during review of production documentation.Without the affected sample, it is not possible to perform root cause analysis.6.Corrective action.Corrective and preventive actions are not necessary as we are not able to determine the root cause of failure.7.Conclusion.Based on these results we cannot confirm this complaint.

• Brand Name: K-ZERO NEEDLELESS CONNECTOR
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): FRESENIUS KABI DEUTSCHLAND GMBH; 5 robert-koch-strasse; bad hersfeld, hessen 36521 ; GM 36521
• MDR Report Key: 18774916
• MDR Text Key: 336190999
• Report Number: 3004548776-2024-00056
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/24/2024,02/25/2024

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: M79400849Y
• Device Lot Number: 32335163
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/24/2024
• Distributor Facility Aware Date: 01/26/2024
• Event Location: Home
• Date Report to Manufacturer: 02/24/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/25/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1