MAUDE Adverse Event Report: MILTENYI BIOTEC GMBH CRYOMACS FREEZING BAGS 750

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	09/13/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The customer complained two cryomacs freezing bags that broke during thawing.The customer did not use a overwrap bag or a freezing casette.The freezing procedure with a controlled rate freezer was not validated by the customer for this type of bags.The bag was stored without overwrap bag and metal casette.Both measures raise safety of the cryomacs bag.For both lots the complaint rate regarding breakage is below 0.01%.

• Brand Name: CRYOMACS FREEZING BAGS 750
• Common Device Name: CRYOMACS FREEZING BAGS 750
• Manufacturer (Section D): MILTENYI BIOTEC GMBH; friedrich-ebert-str. 68; bergisch gladbach, 51429 ; GM 51429
• MDR Report Key: 9172180
• Report Number: 3005290010-2019-00005
• Device Sequence Number: 2323600
• Product Code: KSR
• UDI-Device Identifier: 04049934000300
• UDI-Public: 04049934000300
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 10/09/2019

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 Model Number: N/A
• Device Catalogue Number: 200-074-403
• Device Lot Number: 6181026001, 6190220015
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 10/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1