MAUDE Adverse Event Report: ORIGEN BIOMEDICAL INC. CRYOGENIC STORAGE BAG; CONTAINER, FROZEN DONAL TISSUE STORAGE

Lot Number T50281-3N

Device Problem Material Perforation (2205)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/19/2018

Event Type  malfunction  

Event Description

During infusion of stem cell transplant the 9th and final bag of cells was perforated during spiking; no cells were lost at that time.The second rn applied hemostat to area of tear and it was placed too low and approx.10cc of cells were lost when the bag was flipped over to hang.Two more hemostats were placed and the remaining cells were infused without difficulty.

• Brand Name: CRYOGENIC STORAGE BAG
• Type of Device: CONTAINER, FROZEN DONAL TISSUE STORAGE
• Manufacturer (Section D): ORIGEN BIOMEDICAL INC.
• MDR Report Key: 8343369
• MDR Text Key: 136994683
• Report Number: MW5084094
• Device Sequence Number: 1
• Product Code: LPZ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: T50281-3N
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR