MAUDE Adverse Event Report: MILTENYI BIOTEC GMBH CRYOMACS FREEZING BAGS 250

Model Number N/A

Device Problems Fracture (1260); Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 03/10/2017

Event Type  malfunction  

Manufacturer Narrative

Not returned to the manufacturer.

Event Description

The customer complained on cracked cryomacs® freezing bag(s) 250 which were either removed from the liquid nitrogen freezer at their facility in (b)(6), us or transported to customers in the (b)(4) via plane using a cryo-containment unit (< -160 c).The vrhole freezing/thawing process as well as the amount of cracked bags for each lot described by the customer is actually rather unclear.Also the transport conditions for long-distance transport to (b)(4) customers is not comprehensively described by pct.Up to now there is also no information provided by the customer on the clinical outcome for the patients involved.The date of event is also unknown.

• Brand Name: CRYOMACS FREEZING BAGS 250
• Type of Device: CRYOMACS FREEZING BAGS 250
• 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 ; 120 beacon st; suite 200; somerville, MA 02143 ; 6172180062
• MDR Report Key: 6501096
• MDR Text Key: 73117271
• Report Number: 3005290010-2017-00011
• Device Sequence Number: 1
• Product Code: LPZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 04/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/13/2018
• Device Model Number: N/A
• Device Catalogue Number: 200-074-401
• Device Lot Number: 6150213015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2015
• 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