MAUDE Adverse Event Report: MILTENYI BIOTEC B.V. & CO. KG CRYOMACS FREEZING BAG 50

Catalog Number	200-074-400
Medical Device Problem Codes	Crack (1135); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a bag breakage after thawing.A small crack was observed at the edge of the bag.According to the questionnaire the following investigation and statements could be made: the event was observed during thawing.The customer did use a metal cassette for freezing but did not provide information if it was used for storage as well.A controlled rate freezer was used.An overwrap bag was not used for freezing.The filling volume was 20 ml (10 - 20 ml are recommended for cryomacs freezing bag 50).The freezing bag was stored in the gas phase of ln2.According to the pictures the cryomacs freezing bag 50 is cracked at one of the edges.For the cryomacs freezing bag 50 batch 7220900414 with regard to the complaint, no deviation concerning the manufacturing process occurred.No anomalies occurred during the process.The issue is likely caused by physical stress, e.G.Mechanical impact in combination with an improper user handling during the freezing procedure.The cryomacs freezing bags are very sensitive when frozen and it is strongly recommended to freeze the cryomacs freezing bags according to the recommended freezing procedure.Using a metal cassette for freezing as well as for storage is necessary.Although recommended in the product insert an overwrap bag was not used.The complaint rate for this failure for this lot is below 0.01%.
Additional Manufacturer Narrative
Medical device problem code 3191 "opening causing substantial loss of material after thawing.

• Brand Name: CRYOMACS FREEZING BAG 50
• Common Device Name: CRYOMACS FREEZING BAG 50
• Manufacturer (Section D): MILTENYI BIOTEC B.V. & CO. KG; friedrich-ebert-str. 68; bergisch gladbach, 51429 ; GM 51429
• Manufacturer Contact: bettina-judith höhlich ; friedrich-ebert-str. 68; bergisch gladbach, 51429 ; GM 51429
• MDR Report Key: 18118260
• Report Number: 3005290010-2023-00014
• Device Sequence Number: 12638209
• Product Code: KSR
• UDI-Device Identifier: 04049934000270
• UDI-Public: 4049934000270
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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 Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/13/2023

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: 200-074-400
• Device Lot Number: 7220900414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 11/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown