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

Model Number 74403

Device Problems Crack (1135); Detachment of Device or Device Component (2907); Appropriate Term/Code Not Available (3191)

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

Event Date 05/18/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

When thawing a cryomacs freezing bag 750 the customer noticed that one of the bags was leaking by one of the ports.The bag has been discarded.The patient was treated with backup material.(b)(4).For the freezing bag (b)(4) batch 7210800407, no deviation concerning the manufacturing process occurred.No anomalies occurred during the process.

• Brand Name: CRYOMACS FREEZING BAGS 750
• Type of Device: CRYOMACS FREEZING BAGS 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: 17197341
• MDR Text Key: 317825175
• Report Number: 3005290010-2023-00009
• Device Sequence Number: 1
• Product Code: KSR
• UDI-Device Identifier: 04049934000300
• UDI-Public: 04049934000300
• 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,Followup
• Report Date: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 74403
• Device Catalogue Number: 200-074-403
• Device Lot Number: 7210800407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2023
• 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