MAUDE Adverse Event Report: CSL BEHRING LLC MIX2VIAL; SET, I.V. FLUID TRANSFER

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/14/2023

Event Type  malfunction  

Event Description

A nurse attached the vial adapters that come with the medication to the vials and then connected the vials per the mfg instructions.The adapters are supposed to facilitate the transfer of the diluent to the drug for reconstitution once the vials are connected.The diluent did not transfer to the medication vial.The adapter system did not work.Drug: kcentra 800-1240 iu vial, mfg: cls behring llc, ndc: 63833-0387-02, lot on powder vial: p100503324 exp: 5/20/25, lot on diluent vial: p100491458 exp: 10/12/27.

• Brand Name: MIX2VIAL
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): CSL BEHRING LLC; 1201 n kinzie ave; bradley IL 60915
• MDR Report Key: 17370066
• MDR Text Key: 319486578
• Report Number: 17370066
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/19/2023

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
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/19/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/21/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1