MAUDE Adverse Event Report: UNKNOWN ADAPTER IV VENTED SPIKE; SET, I.V. FLUID TRANSFER

Device Problems Device Difficult to Setup or Prepare (1487); Insufficient Flow or Under Infusion (2182); Structural Problem (2506)

Patient Problem Malaise (2359)

Event Type  malfunction  

Event Description

Spontaneous, home health rn called in stating the last vial of gamunex was compromised.When she went to use the spike, the entire black rubber piece from the bottle ended up in the vial, she feels the spike was too large.She was only able to infuse 20 out of 30 grams.No missed dose but pt received partial dose.Pt is feeling sick (not specified] due to partial dose.Md aware.Unknown if spike is on hand for return.No further information provided.Used to infuse gamunex-c 10% at above dose/frequency.Reported to cvs/caremark by: health professional.

• Brand Name: ADAPTER IV VENTED SPIKE
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 16042911
• MDR Text Key: 306249916
• Report Number: MW5113953
• Device Sequence Number: 1
• 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: 12/19/2022

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
• Device Expiration Date: 02/17/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2022
• Patient Sequence Number: 1
• Treatment: GAMUNEX.
• Patient Sex: Male