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

Catalog Number	200-074-402
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports a cracked freezing bag 500 (7200600613).The bag was not investigated.A filled questionnaire and pictures were available.According to the questionnaire the following investigation and statements could be made: the event was observed during freezing/storage.The customer did use a metal cassette for freezing.No statement is made, if it was used for storage.A controlled rate freezer was used.An overwrap bag was not 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 pictures the freezing bag is cracked over the entire bag.The pictures show, that there was a big loose label attached to the freezing bag and was put onto the bag inside the metal cassette.The issue is likely caused by physical stress, e.G.Mechanical impact in combination with a wrong user handling.There are several deviations from the recommended freezing procedure.An overwrap bag was not used for freezing.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 loose label attached to the freezing bag and put into the metal cassette during freezing affect the product safety during the freezing process.A typical cause for this pattern of cracks is the presence of air bubbles.According to the pictures, in this case, no air bubbles are visible inside the freezing bag, but it cannot be ruled out.Air should absolutely be avoided in the sealed freezing bags as it will expand after during thaw and may cause a bag breakage.For the freezing bag 500 batch 7200600613, no deviation concerning the manufacturing process occurred.No anomalies occurred during the process.(b)(4).

• 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: 14375042
• Report Number: 3005290010-2022-00003
• Device Sequence Number: 14629208
• Product Code: KSR
• UDI-Device Identifier: 04049934000294
• UDI-Public: 4049934000294
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: BK090020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2022

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: 7200600613
• 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: 04/11/2022
• Initial Report FDA Received Date: 05/12/2022
• 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