MAUDE Adverse Event Report: MILTENYI BIOTEC B.V. & CO. KG CRYOMACS FREEZING BAGS 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	06/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer had an instance in which they noted 3 of 4 cryomacs freezing bags had cracked.The cracks were noted when staff was retrieving products from a rack in ln2 storage.One bag was lost due to the incident.Other affected bags either thawed under bsc and transplanted or remained frozen.For the investigation a filled in questionaire was available.According to the questionnaire the following investigation and statements could be made: · the events were observed during thaw.· the customer did use metal cassettes for freezing, but no statement is made if metal cassettes were used for storage.· a controlled rate freezer was used.· an overwrap bag was not used.· the filling volume was 60 ml (30 to 70 ml are recommended).· the cryomacs freezing bag was stored in the vapor phase of ln2.Pictures were not available for investigation.For the cryomacs freezing bag 250 batch 7220400221 no deviation concerning the manufacturing process occurred.No anomalies occurred during the process the incident rate for this lot for this failure is below 0.01% 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 questionnaire an overwrap bag was not used.This is a deviation from the recommended freezing procedure.Frozen bags are sensitive towards mechanical stress due to the nature of the material.Please handle frozen bags with extra care.
Additional Manufacturer Narrative
3191 (a27) - appropriate term/code not available: "opening causing substantial loss of material after thawing".

• Brand Name: CRYOMACS FREEZING BAGS 250
• Common Device Name: CRYOMACS FREEZING BAGS 250
• Manufacturer (Section D): MILTENYI BIOTEC B.V. & CO. KG; friedrich-ebert-str. 68; bergisch gladbach, 51429 ; GM 51429
• Manufacturer (Section G): 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: 17324228
• Report Number: 3005290010-2023-00010
• Device Sequence Number: 12139891
• 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): 07/01/2023

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: 7220400221
• 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: 06/19/2023
• Initial Report FDA Received Date: 07/14/2023
• 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