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

Model Number	M79400849
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The following has been reported: per email from the fresenius kabi sales development representative southeast on 11/7/2025: "i have had a few complaints come from our customer (b)(6) hospital, regarding the k-zero needless connectors "popping off" and not securing onto non-dedicated sets.This happened during patient care and concerned the hospital, nurses, patient, etc.Per previous order history from this customer, the k-zero connector they order is the m79400849 connector." no adverse events reported.No sample available.No picture available.1.Reported complaint: problems with medication port.2.Quantity of sample(s): we did not receive any sample or picture for investigation.3.Concerned product code / batch: k-zero needleless connector, (m79400849), unknown.4.Investigation report: we have not received a complaint sample for investigation.As we did not receive the batch number, an inspection of retained samples and review of batch documentation was not possible.Without faulty sample and batch number, a more detailed investigation was not possible.In the last 12 months (from 20.11.2024 to 19.11.2025) we have received 2 complaints for this article with the same reason as "problems with medication port".5.Root cause: without the complaint sample and batch number root cause analysis is not possible.6.Corrective action: corrective and preventive actions are not necessary as the complaint reason is not reproducible for us.7.Conclusion: based on these results we are not able to confirm this complaint.

• Brand Name: K-ZERO
• Common Device Name: NEEDLELESS CONNECTOR
• Manufacturer (Section D): FRESENIUS KABI DEUTSCHLAND GMBH; 5 robert-koch-strasse; bad hersfeld, hessen 36521 ; GM 36521
• MDR Report Key: 23722293
• Report Number: 3004548776-2025-00623
• Device Sequence Number: 15586447
• Product Code: FPA
• UDI-Device Identifier: 04250273735949
• UDI-Public: 04250273735949
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/04/2025
• Report Date (Section F): 12/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M79400849
• Device Catalogue Number: M79400849
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/07/2025
• Event Location: Hospital
• Date Report to Manufacturer: 12/04/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/04/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 12/04/2025