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

Catalog Number	200-074-403
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A fsn has been initiated on request of the finish authority.It is planned to notify customers about the potential problem.The lot has not been on sale in the us, therefore no fsn is initiated for the us.Decision for the fsn was on (b)(6) 2021.Products of this lot sent out after this date have been 100% inspected and are released to the market in agreement with the finish authority.
Event or Problem Description
For cryomacs freezing bag 750 the customer observed that in the lot 7200700537 there is a small "pocket" in the upper corner of the bag and the cell suspension is able to access that pocket.At least in one of the bags there was also a hole at the end of the pocket, so cell suspension was able to leak out from the bag and the suspension was subjected to outside contamination as well.The customer provided pictures of the affected bag.The issue described for this single bag, where an open channel to the outside occured, could potentially lead to the loss of a small amount of material and contamination.The customer described another case, where cell suspension leaked into the pocket but not to the outside.This is not considered a reportable event, because no loss of cells or contamination is possible.The customer also describes bags with pockets.The formation of pockets occurs in regular products and is at this time point no indication of a leakage problem.The bags were retrieved from the customer, investigated and found to have no fail.

• Brand Name: CRYOMACS FREEZING BAG 750
• Common Device Name: CRYOMACS FREEZING BAG 750
• Manufacturer (Section D): MILTENYI BIOTEC B.V. & CO. KG; friedrich-ebert-str. 68; bergisch gladbach, 51429 ; GM 51429
• MDR Report Key: 11271970
• Report Number: 3005290010-2021-00002
• Device Sequence Number: 4371601
• Product Code: KSR
• UDI-Device Identifier: 04049934000300
• UDI-Public: 4049934000300
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: BK090020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 02/03/2021

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 Catalogue Number: 200-074-403
• Device Lot Number: 7200700537
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2021
• Initial Report FDA Received Date: 02/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1