MAUDE Adverse Event Report: BAG ++ 2000ML GRAVITY 3 LEG; CONTAINER, I.V.

Device Problem Break (1069)

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

Event Date 09/23/2021

Event Type  malfunction  

Event Description

Spontaneous inbound call from gamunex infusion nurse informing that the 3-leg bag broke and nurse had to throw away bag, nurse is using next week's gamunex c for this week's infusion and will need 1 vial of each gamunex reshipped.No missed dose, no adverse event reported, unknown if product available for return, unknown lot/exp date.No further info.Indication: chronic inflammatory demyelinating polyneuritis.Reported to (b)(6) by health professional.

• Brand Name: BAG ++ 2000ML GRAVITY 3 LEG
• Type of Device: CONTAINER, I.V.
• MDR Report Key: 12547574
• MDR Text Key: 274114494
• Report Number: MW5104280
• Device Sequence Number: 1
• Product Code: KPE
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 35 YR