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

Model Number	74401
Medical Device Problem Codes	Fracture (1260); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
3191 (a27) - appropriate term/code not available (the device problem is not adequately described by any other term.) "opening causing substantial loss of material after thawing".
Event or Problem Description
The customer reported a breakage upon thawing of a cryomacs freezing bag 250, lot 7220100316.Pictures and a filled in questionaire were provided by the customer.According to the questionnaire the following investigation and statements could be made: the event were observed during thaw.The customer did use metal cassettes for freezing and for storage.A controlled rate freezer was used.An overwrap bag was not used for freezing.The filling volume was 60 ml (30 - 70 ml are recommended).The freezing bag was stored in the vapor phase of ln2.According to the pictures the bag is cracked over the entire bag.The crack starts near the spike ports at the upper part of the bag and leads to the middle of the bag.According to the pictures it can be suspected that there was a big air bubble trapped inside the bag.The issue is likely caused by physical stress, e.G.Mechanical impact in combination with an improper user handling during the freezing procedure.According to the pictures it is suspected, that a big air bubble was trapped inside the bag.Air should absolutely be avoided in the sealed freezing bags as it will expand after the freezing process and may cause a bag breakage.According to the questionnaire no overwrap bag was used which is also a deviation from the recommended freezing process.The incident rate for this type of failure for this lot is below 0.01%.For the cryomacs freezing bag 250 batch 7220100316, with regard to the complaint, no deviation concerning the manufacturing process occurred.No anomalies occurred during the process.

• 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
• Manufacturer Contact: bettina-judith höhlich ; friedrich-ebert-str. 68; bergisch gladbach, 51429 ; GM 51429
• MDR Report Key: 16636157
• Report Number: 3005290010-2023-00006
• Device Sequence Number: 17966728
• Product Code: KSR
• UDI-Device Identifier: 04049934000287
• UDI-Public: 04049934000287
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 03/29/2023

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 Model Number: 74401
• Device Catalogue Number: 200-074-401
• Device Lot Number: 7220100316
• 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: 03/10/2023
• Initial Report FDA Received Date: 03/29/2023
• 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