MAUDE Adverse Event Report: MILTENYI BIOTEC B.V. & CO. KG CRYOMACS FREEZING BAG 500

Model Number	74402
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/15/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a breakage during thawing.During taking out from the liquid nitrogen container, the overwrap bag burst, and the freezing bag with the product inside broke in two.For investigation a picture and a description of the customer where available.The customer did not provide a filled in detailed questionnaire.Based on this limited information more than one scenario is possible.It seems likely that the bag was either stored in the liquid nitrogen phase without allowing trapped liquid nitrogen to evaporate for at least 4h.Alternatively, air might have been trapped in the cryomacs freezing bag.It can also not be excluded that the breakage occurred due to physical stress during handling.A review of the complaints reported for this lot resulted in no other similar cases (breakage upon thawing).

• Brand Name: CRYOMACS FREEZING BAG 500
• Common Device Name: CRYOMACS FREEZING BAG 500
• Manufacturer (Section D): MILTENYI BIOTEC B.V. & CO. KG; friedrich-ebert-str. 68; bergisch gladbach, 51429 ; GM 51429
• MDR Report Key: 10033084
• Report Number: 3005290010-2020-00012
• Device Sequence Number: 11445352
• Product Code: KSR
• UDI-Device Identifier: 04049934000294
• UDI-Public: 04049934000294
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• 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): 05/07/2020

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 Expiration Date: 05/07/2022
• Device Model Number: 74402
• Device Catalogue Number: 200-074-402
• Device Lot Number: 6190617021
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2020
• Initial Report FDA Received Date: 05/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1