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 (b)(4) 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
• Manufacturer (Section G): FRESENIUS KABI DEUTSCHLAND GMBH; 5 robert-koch-strasse; bad hersfeld, hessen 36521 ; GM 36521
• Manufacturer Contact: rebecca mccandless ; 3 corporate drive; lake zurich, IL 60047
• MDR Report Key: 23722354
• Report Number: 9681819-2025-00007
• Device Sequence Number: 10464852
• Product Code: FPA
• UDI-Device Identifier: 04250273735949
• UDI-Public: 04250273735949
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K162826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown