MAUDE Adverse Event Report: MILTENYI BIOTEC B.V. & CO. KG CRYOMACS FREEZING BAG 750

Model Number	74403
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	04/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During the thawing of 2 bags of cryopreserved hematopoietic stem cells for a patient, pharmacists found that one of the 2 bags had completely leaked.The product was therefore transferred to an overbag.However, due to the risk of contamination of the cracked bag the graft was destroyed.The backup bag was administered to the patient.This is the first complaint for this lot with a complaint rate below 0.01%.For the cryomacs freezing bag 750 batch 7220500802, with regard to the complaint, no deviation concerning the manufacturing process occurred.No anomalies occurred during the process.The customer provided pictures but no filled in questionaire with detailed information.According to the pictures the issue can be confirmed.There is a crack at the edge at the bottom of the bag.According to the description it is suspected that no overwrap bag was used for freezing.Due to the lack of information a root cause cannot be determined.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 description it is suspected that an overwrap bag was not used for freezing.This is a deviation from the recommended freezing procedure.
Additional Manufacturer Narrative
3191 - appropriate term/code not available: opening causing substantial loss of material after thawing.

• Brand Name: CRYOMACS FREEZING BAG 750
• Common Device Name: CRYOMACS FREEZING BAG 750
• 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: 16874383
• Report Number: 3005290010-2023-00007
• Device Sequence Number: 5822414
• Product Code: KSR
• UDI-Device Identifier: 04049934000300
• UDI-Public: 04049934000300
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 05/04/2023

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: 74403
• Device Catalogue Number: 200-074-403
• Device Lot Number: 7220500802
• 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: 04/11/2023
• Initial Report FDA Received Date: 05/05/2023
• 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