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

Catalog Number	200-074-401
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a cryomacs freezing bag 250 (200-074-401; 7200500219) that broke during thawing.The patient was treated with backup material.

• Brand Name: CRYOMACS FREEZING BAG 250
• Common Device Name: CRYOMACS FREEZING BAG 250
• Manufacturer (Section D): MILTENYI BIOTEC B.V. & CO. KG; friedrich-ebert-str. 68; bergisch gladbach, 51429 ; GM 51429
• MDR Report Key: 11397424
• Report Number: 3005290010-2021-00004
• Device Sequence Number: 3359393
• Product Code: KSR
• UDI-Device Identifier: 04049934000287
• UDI-Public: 4049934000287
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• 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): 03/01/2021

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: 200-074-401
• Device Lot Number: 7200500219
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 03/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1