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

Catalog Number	200-074-402
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a cracked cryomacs bag 500 after thawing with content leaking.It was an autologous stem cell preparation from a patient.The customer reports a cracked freezing bag 500 (7210700504).The bag was not investigated.A filled questionnaire was available.A picture was 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.· no overwrap bag was used.· the filling volume was 100 ml (55 - 100 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 edge of the bag.A big adhesive label was put onto the freezing bag.The issue is likely caused by physical stress, e.G.Mechanical impact in combination with a wrong user handling.An overwrap bag was not used for freezing.This is a deviation from the recommended freezing procedure.Another deviation is the labeling.It is recommended to place an identification tag into the label pocket of the freezing bag.It cannot be excluded, that a big label put onto the freezing bag during freezing affects the product safety during the freezing process.It is important to follow the recommendations for the freezing procedure as the bag material is sensitive.For the freezing bag 500 batch 7210700504, no deviation concerning the manufacturing process occurred.No anomalies occurred during the process.The complaint rate for this type of failure for this lot is below 0.01%.

• Brand Name: CRYOMACS FREEZING BAG 500
• Common Device Name: CRYOMACS FREEZING BAG 500
• 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: 15320024
• Report Number: 3005290010-2022-00006
• Device Sequence Number: 12069754
• Product Code: KSR
• UDI-Device Identifier: 04049934000294
• UDI-Public: 4049934000294
• 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
• Report Date (Section B): 08/30/2022

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: 200-074-402
• Device Lot Number: 7211000574
• 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: 08/04/2022
• Initial Report FDA Received Date: 08/30/2022
• 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