MAUDE Adverse Event Report: MILTENYI BIOTEC B.V. & CO. KG CRYOMACS FREEZING BAGS 250

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a broken bag.The bag was frozen using a controlled rate freezer.Upon completion of freeze cycle, bag was transferred to a ln2 vapor phase freezer.Product stored in a metal cassette.On day 7th, the cassette containing the product was removed from the vapor phase freezer and transferred immediately to a bed of dry ice (small pellet variety).Cassette was buried within dry ice for approximately 20 minutes while awaiting inspection.When cassette was opened to perform inspection/verification for product transfer, the broken bag was discovered.For the investigation pictures where provided.The customer did not use a metal cassette for freezing and no overwrap bag as recommended.Air bubbles are visible in the bag.A likely reason for this issue is, that not all air was removed from the bag.Air has to absolutely be avoided as it expands during thawing and can cause cracks.The customer did also not use an overwrap bag as well as a metal cassette for the freezing process as recommended.This can have contributed as well.The complaint rate for this lot is low with (b)(4) (including a case with a different failure).

• Brand Name: CRYOMACS FREEZING BAGS 250
• Common Device Name: CRYOMACS FREEZING BAGS 250
• Manufacturer (Section D): MILTENYI BIOTEC B.V. & CO. KG; friedrich-ebert-str. 68; bergisch gladbach, 51429 ; GM 51429
• MDR Report Key: 9731401
• Report Number: 3005290010-2020-00009
• Device Sequence Number: 366961
• Product Code: KSR
• UDI-Device Identifier: 04049934000287
• UDI-Public: 04049934000287
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: BK090020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/10/2021
• Device Model Number: N/A
• Device Catalogue Number: 200-074-401
• Device Lot Number: 6190110027
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1