MAUDE Adverse Event Report: MILTENYI BIOTEC B.V. & CO. KG CRYOMACS FREEZING BAG 250

Model Number 74401

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

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

Event Date 02/17/2023

Event Type  malfunction  

Event Description

The customer observed a leak while injecting cells into a cryomacs bag 250.40 ml of the cell product were lost.The patient was treated with backup material.The investigation based on descriptions of the customer showed that the white cap of the injection port of the connector set fell off.This was caused by a loose luer connection of the white cap of the injection port at the connector set.Possible causes are that the luer connection was not fastened enough during production of the connector set or got loose during production of the cryomacs freezing bag itself.Also transport movements can cause loosening of the connection.It can also not be excluded that it was loosened during use at the customer's site.For the cryomacs freezing bag 250 batch 7211100355, no deviation concerning the manufacturing process occurred.No anomalies occurred during the process.The incident rate for this issue is below 0.01%.

Manufacturer Narrative

3191 - appropriate term/code not available: opening causing substantial loss of material during filling.

• Brand Name: CRYOMACS FREEZING BAG 250
• Type of Device: CRYOMACS FREEZING BAG 250
• 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: 16520443
• MDR Text Key: 311129540
• Report Number: 3005290010-2023-00004
• Device Sequence Number: 1
• Product Code: KSR
• UDI-Device Identifier: 04049934000287
• UDI-Public: 04049934000287
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 74401
• Device Catalogue Number: 200-074-401
• Device Lot Number: 7211100355
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1