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	12/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a crack on the bag after freezing.The crack is on the middle of the bag and the length of the crack is long.The customer did not use an overwrap bag to stabilize the bag and enable rescue of the frozen material.This is the first complaint for this lot with a incident rate below 0.01%.

• 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: 9563318
• Report Number: 3005290010-2020-00002
• Device Sequence Number: 16869364
• Product Code: KSR
• UDI-Device Identifier: 04049934000287
• UDI-Public: 04049934000287
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 01/08/2020

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: 12/14/2019
• Initial Report FDA Received Date: 01/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1