MAUDE Adverse Event Report: MILTENYI BIOTEC INC. CRYOMACS FREEZING BAG 250; CONTAINER, FROZEN DONOR TISSUE STORAGE

Catalog Number 200-074-401

Device Problem Fracture (1260)

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

Event Date 06/10/2020

Event Type  malfunction  

Event Description

On (b)(6) 2020, the (b)(6) laboratory technologist was verifying the backup dose of cells (autologous cryopreserved hpc, apheresis) in storage for a patient who will undergo a second transplant as part of their cancer treatment.Their cells were collected on (b)(6) 2014 and have been in storage since this time.Upon visually inspecting the cryo bags while verifying the product cells are present and intact, the (b)(6) laboratory technologist discovered a fracture on one of the cryo bags extending from the base of the bag to the top of the bag just under the access port.The patient has an acceptable cell dose to proceed to transplant with the remaining intact product.Review of deviation reporting does not indicate a trend of integrity failures in association with the affected cryo bag lot and/or any other lot of cryo bag.Fda safety report id # (b)(4).

• Brand Name: CRYOMACS FREEZING BAG 250
• Type of Device: CONTAINER, FROZEN DONOR TISSUE STORAGE
• Manufacturer (Section D): MILTENYI BIOTEC INC.
• MDR Report Key: 10188740
• MDR Text Key: 196405863
• Report Number: MW5095159
• 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: 06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Catalogue Number: 200-074-401
• Device Lot Number: 6121120003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 53