MAUDE Adverse Event Report: MILTENYI BIOTEC GMBH CRYOMACS FREEZING BAGS 500

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation revealed that the customer did not use the provided overwrap bag to raise product safety.The overwrap bag increases stability and allows to rescue the cells in case of breakage of the freezing bag.The complaint rate for this lot is below 0.01% with only this incident.
Event or Problem Description
The customer complained a ruptured cryomacs freezing bag after removal from the liquid nitrogen tank.No overwrap bag was used.The patient received a backup product for transplantation.The customer stated that the dose was considered to be sufficient.

• Brand Name: CRYOMACS FREEZING BAGS 500
• Common Device Name: CRYOMACS FREEZING BAGS 500
• Manufacturer (Section D): MILTENYI BIOTEC GMBH; friedrich-ebert-str. 68; bergisch gladbach, 51429 ; GM 51429
• MDR Report Key: 8950782
• Report Number: 3005290010-2019-00003
• Device Sequence Number: 2418252
• Product Code: KSR
• UDI-Device Identifier: 04049934000294
• UDI-Public: 04049934000294
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: BK090020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/30/2019

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: N/A
• Device Catalogue Number: 200-074-402
• Device Lot Number: 6181214013
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/30/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 08/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1