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

Catalog Number	200-074-402
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported several bags, that did not fit into the overwrap bag.For one bag the customer had to refill the material into another bag.The others were determined prior to use.The case is under investigation by the production department.
Event or Problem Description
A customer reported several bags, that did not fit into the overwrap bag.For one bag the customer had to refill the material into another bag.The others were determined prior to use.The investigation in the production department determined that due to a line clearance error, the box of cryomacs freezing bags 500 contained some cryomacs freezing bags of a lager size (cryomacs freezing bags 750).The associated risk has a minor severity (s2).Due to the low risk and as no fatal harm (death, permanent disability / disease / injury; surgical or intensive care medical) is affected, the incident is not considered as serious and therefore not reportable.A corrective action has been initiated to mitigate the current issue by notifying other potentially affected customers.In addition, capa actions have been defined to prevent a reoccurence.

• 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: 20301058
• Report Number: 3005290010-2024-00008
• Device Sequence Number: 12933268
• Product Code: KSR
• UDI-Device Identifier: 04049934000294
• UDI-Public: 04049934000294
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 09/25/2024

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: 7231200026
• 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: 08/27/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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