MAUDE Adverse Event Report: MILTENYI BIOTEC B.V. & CO. KG 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	10/25/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Right after the thawing of the cryomacs freezing bag containing stem cells, the operator noticed a leak at the connection between tube and bag.The patient was treated with backup material.The cryomacs freezing bag probably broke due to mechanical stress during handling.The overwrap bag provided with the freezing bag was not used for storage to stabilize the bag and if necessary rescue the cells.No metal cassette was used for storage.Both steps are described in the product information sheet.The complaint database was analysed for similar incidents with this lot.This was found to be the second complaint with a breakage of the bag for this lot.For this lot so far (b)(4) boxes with (b)(4) bags have been sold.The complaint rate is (b)(4).

• Brand Name: CRYOMACS FREEZING BAGS 750
• Common Device Name: CRYOMACS FREEZING BAGS 750
• Manufacturer (Section D): MILTENYI BIOTEC B.V. & CO. KG; friedrich-ebert-str. 68; bergisch gladbach, 51429 ; GM 51429
• MDR Report Key: 9370529
• Report Number: 3005290010-2019-00006
• Device Sequence Number: 2708950
• Product Code: KSR
• UDI-Device Identifier: 04049934000300
• UDI-Public: 04049934000300
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: BK090020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/21/2019

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 Expiration Date: 01/20/2022
• Device Model Number: N/A
• Device Catalogue Number: 200-074-403
• Device Lot Number: 6190220015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 11/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1