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

Model Number N/A

Device Problem Torn Material (3024)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Device was not returned.

Event Description

A breakage in the upper right corner of a cryomacs freezing bag 500 upon removal from liquid nitrogen tank was reported by the customer.The customer stated that there was sufficient cellular material in place to treat the patient accordingly, therefore, a risk for the patient could be ruled out.The event happened in (b)(6) 2016.The exact date is unknown.

• Brand Name: CRYOMACS FREEZING BAG 500
• Type of Device: FREEZING BAG
• Manufacturer (Section D): MILTENYI BIOTEC GMBH; friedrich-ebert-strasse 68; bergisch gladbach, 51429 ; GM 51429
• Manufacturer (Section G): MILTENYI BIOTEC GMBH; friedrich-ebert-strasse 68; bergisch gladbach, 51429 ; GM 51429
• Manufacturer Contact: nancy johansen ; 85 hamilton st; cambridge, MA 02139 ; 6172180062
• MDR Report Key: 5617506
• MDR Text Key: 43984436
• Report Number: 3005290010-2016-00064
• Device Sequence Number: 1
• Product Code: LPZ
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: BK090020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2014
• Device Model Number: N/A
• Device Catalogue Number: 200-074-402
• Device Lot Number: 6110729005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/19/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1