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

Catalog Number	200-074-403
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	02/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
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 per bag is 120 ml (80 - 190 ml are recommended).· the freezing bags were stored in the vapor phase of ln2.According to the pictures the issue can be confirmed.The cryomacs freezing bag is cracked.There is a long crack which leads from the bottom of the bag to the centre of the bag.There is another small crack at the bottom of the bag.According to the pictures the cracked bag is placed in a transparent bag.It is suspected, that it was not frozen in the transparent bag.According to the description of the customer it cannot be excluded that the issue is caused due to squeezing through the freezer cassette at the bottom of the bag.For the cryomacs freezing bag 750 batch 7230600613, with regard to the complaint, no deviation concerning the manufacturing process occurred.No anomalies occurred during the process.This is the first complaint of this type for this lot with a incident rate below (b)(4).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 pictures the assumption of the customer can be confirmed.The issue likely occurred due to squeezing through the freezer cassette at the bottom of the bag.The cracks at the bottom of the bag which can be seen on the pictures would correspond to the cause.According to the questionnaire no overwrap bag was used.The cryomacs freezing bags are very sensitive when frozen and it is strongly recommended to freeze the cryomacs freezing bags according to the recommended freezing procedure.
Additional Manufacturer Narrative
Imdrf a code 3191 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: 18895445
• Report Number: 3005290010-2024-00004
• Device Sequence Number: 20380536
• Product Code: KSR
• UDI-Device Identifier: 04049934000300
• UDI-Public: 04049934000300
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2024

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: 200-074-403
• Device Lot Number: 7230600613
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 03/13/2024
• 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