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

Model Number	74401
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2023
Type of Reportable Event	Malfunction
Event or Problem 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%.
Additional Manufacturer Narrative
3191 - appropriate term/code not available: opening causing substantial loss of material during filling.

• Brand Name: CRYOMACS FREEZING BAG 250
• Common Device Name: 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
• Report Number: 3005290010-2023-00004
• Device Sequence Number: 14076817
• Product Code: KSR
• UDI-Device Identifier: 04049934000287
• UDI-Public: 04049934000287
• Combination Product (Y/N): N
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/10/2023

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 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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