MAUDE Adverse Event Report: MILTENYI BIOTEC B.V. & CO. KG CRYOMACS FREEZING BAG 750

Catalog Number	200-074-403
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer described and provided photos of an incident where the outer and inner cryopreservation bags broke.This was noticed when opening the cassette.Customer followed internal sop, ultimately transferred the rest of the contents into a new bag under a laminar flow hood.Initial material was 150 ml and 98 mls were saved.

• Brand Name: CRYOMACS FREEZING BAG 750
• Common Device Name: CRYOMACS FREEZING BAG 750
• Manufacturer (Section D): MILTENYI BIOTEC B.V. & CO. KG; friedrich-ebert-str. 68; bergisch gladbach, 51429 ; GM 51429
• MDR Report Key: 11588049
• Report Number: 3005290010-2021-00007
• Device Sequence Number: 3496066
• Product Code: KSR
• UDI-Device Identifier: 04049934000300
• UDI-Public: 4049934000300
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: BK090020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/30/2021

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 Catalogue Number: 200-074-403
• Device Lot Number: 7200700537
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 03/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1