MAUDE Adverse Event Report: MILTENYI BIOTEC B.V. & CO. KG CRYOMACS FREEZING BAG 50

Model Number N/A

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/17/2020

Event Type  malfunction  

Event Description

The customer reported a detachment of a port after removal from the microbiological safety cabinet.The material was discarded due to sterility concerns.The customer stated that the patient was not seriously harmed, likely due to available backup material.The investigation showed that a luer connection was loose.Either the cap was not sufficiently fastened during production or it became loose due to transport movements.This is the first complaint with this failure for this lot with a complaint rate below (b)(4).

• Brand Name: CRYOMACS FREEZING BAG 50
• Type of Device: CRYOMACS FREEZING BAG 50
• 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: 9719713
• MDR Text Key: 191917533
• Report Number: 3005290010-2020-00008
• Device Sequence Number: 1
• Product Code: KSR
• UDI-Device Identifier: 04049934000270
• UDI-Public: 04049934000270
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: BK090020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2021
• Device Model Number: N/A
• Device Catalogue Number: 200-074-400
• Device Lot Number: 6180314024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2020
• 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