MAUDE Adverse Event Report: MILTENYI BIOTEC B.V. & CO. KG CRYOMACS FREEZING BAGS 500

Catalog Number	200-074-402
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	03/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imdrf a code 3191 defined as opening causing substantial loss of material after thawing.
Event or Problem Description
The customer reported the breakage of a cryomacs freezing bag during thawing.The patient was treated with backup material.For the cryomacs freezing bag 500 batch 7220600550, with regard to the complaint, no deviation concerning the manufacturing process occurred.No anomalies occurred during the process.The incident rate for this lot with and this type of failure is below 0.01%.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 and for storage.A controlled rate freezer was used.An overwrap bag was not used.The filling volume was 99 ml (55 to 100 ml are recommended).The freezing bags were stored in the vapor phase of ln2.According to the pictures the cryomacs freezing bag is cracked.There is a long crack from the upper part of the bag to the bottom.The issue is likely caused by physical stress, e.G.Mechanical impact in combination with an improper user handling during the freezing procedure.No overwrap bag was used.This is a deviation from the recommended freezing procedure.The bag may has been slightly pinched in the metal cassette or the metal cassette in which the frozen bag was stored was roughly moved after freezing and lead to the cracks.There may have been air bubbles trapped inside the frozen material inside the freezing bag.It doesn't necessarily have to lead to a crack, but air should absolutely be avoided in the welded cryomacs freezing bag as it will expand after the freezing process and may cause a bag breakage.

• Brand Name: CRYOMACS FREEZING BAGS 500
• Common Device Name: CRYOMACS FREEZING BAGS 500
• 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: 19131981
• Report Number: 3005290010-2024-00006
• Device Sequence Number: 20546513
• Product Code: KSR
• UDI-Device Identifier: 04049934000294
• UDI-Public: 04049934000294
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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

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: 200-074-402
• Device Lot Number: 7220600550
• 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: 04/08/2024
• Initial Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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