MAUDE Adverse Event Report: HOSPIRA, INC. ADD-VANTAGE; SET, I.V. FLUID TRANSFER

Device Problems Device Markings/Labelling Problem (2911); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Type  malfunction  

Event Description

Tazicef 1 and 2 gm dd-vantage vials (ndc 0409-5093-14 and 0409509211) faulty.Components of the add-vantage mechanism fall into the diluent bag.Note: each photo attached is a separate occurrence.Inadequate package / container protection of drug product.Poor packaging design poor product design: (i.E.Vial, syringe, bag).Error occurred: medication did not reach pt.(b)(6).Submission id: (b)(4).

• Brand Name: ADD-VANTAGE
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): HOSPIRA, INC.
• MDR Report Key: 12924104
• MDR Text Key: 282006781
• Report Number: MW5105742
• Device Sequence Number: 5
• Product Code: LHI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/30/2021
• 7 Devices were Involved in the Event: 1 2 3 4 5 6 7

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/02/2021
• Patient Sequence Number: 1
• Treatment: TAZICEF, MFR: HOSPIRA, INC., INJECTABLE VIAL, NDC: 0409-5093-14