MAUDE Adverse Event Report: MILTENYI BIOTEC B.V. & CO. KG CRYOMACS FREEZING BAG 50

Catalog Number 200-074-400

Device Problems Crack (1135); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2023

Event Type  malfunction  

Event Description

The customer reported a bag breakage after thawing.A small crack was observed at the edge of the bag.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 but did not provide information if it was used for storage as well.A controlled rate freezer was used.An overwrap bag was not used for freezing.The filling volume was 20 ml (10 - 20 ml are recommended for cryomacs freezing bag 50).The freezing bag was stored in the gas phase of ln2.According to the pictures the cryomacs freezing bag 50 is cracked at one of the edges.For the cryomacs freezing bag 50 batch 7220900414 with regard to the complaint, no deviation concerning the manufacturing process occurred.No anomalies occurred during the process.The issue is likely caused by physical stress, e.G.Mechanical impact in combination with an improper user handling during the freezing procedure.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.Using a metal cassette for freezing as well as for storage is necessary.Although recommended in the product insert an overwrap bag was not used.The complaint rate for this failure for this lot is below 0.01%.

Manufacturer Narrative

Medical device problem code 3191 "opening causing substantial loss of material after thawing.

• Brand Name: CRYOMACS FREEZING BAG 50
• Type of Device: CRYOMACS FREEZING BAG 50
• 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: 18118260
• MDR Text Key: 327903984
• Report Number: 3005290010-2023-00014
• Device Sequence Number: 1
• Product Code: KSR
• UDI-Device Identifier: 04049934000270
• UDI-Public: 4049934000270
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: BK090020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 200-074-400
• Device Lot Number: 7220900414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1