MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. APEX¿; SET, I.V. FLUID TRANSFER

Model Number	2112541
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The spike port was faulty on the iv bag resulting in a chemo spill in the infusion center.Our pharmacy only had one other iv bag with this specific lot number.

• Brand Name: APEX¿
• Common Device Name: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown PA 18109
• MDR Report Key: 15064945
• Report Number: 15064945
• Device Sequence Number: 5628190
• Product Code: LHI
• UDI-Device Identifier: 04046964688560
• UDI-Public: 04046964688560
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/15/2022
• Report Date (Section F): 04/15/2022

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: 2112541
• Device Catalogue Number: 2112541
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/20/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/20/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/15/2022