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

Catalog Number	200-074-400
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports a freezing bag 50 (7210700418) with a leakage at the eva tube.The eva tube is ripped at the welding seam.The bag was not investigated.A filled questionnaire was available.Pictures were provided.According to the questionnaire the following investigation and statements could be made: · the event was observed during thaw.· the customer did use a metal cassette for freezing and for storage.· a controlled rate freezer was not used.· an overwrap bag was used, but no statement is made if it was welded and evacuated.· the filling volume was 30 ml (10 - 20 ml are recommended).· the freezing bag was stored in the vapor phase of ln2.According to the picture the freezing bag was cracked at the connection of the eva tube and the bag at the welding seam.The issue is likely caused by physical stress, e.G.Mechanical impact in combination with a wrong user handling.The bag was overfilled.The filling volume was 30 ml.This is a deviation as the recommended filling volume is 10 to 20 ml.A negative impact on the safety of the product cannot be excluded an overwrap bag was used for freezing, but no statement is made if it was welded and evacuated.If not it would be a deviation from the recommended freezing procedure.It is important to follow the recommendations for the freezing procedure as the bag material is sensitive.For the freezing bag 50 batch 7210700418, no deviation concerning the manufacturing process occurred.No anomalies occurred during the process.The incident rate for this failure for this lot is below 0.01%.

• 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: 15494210
• Report Number: 3005290010-2022-00007
• Device Sequence Number: 19280497
• 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): 09/21/2022

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: 7210700418
• 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: 08/30/2022
• Initial Report FDA Received Date: 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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