MAUDE Adverse Event Report: MILTENYI BIOTEC GMBH CRYOMACS FREEZING BAG 50 ML

Model Number FREEZING BAG 50 ML

Device Problems Crack (1135); Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 07/10/2015

Event Type  malfunction  

Manufacturer Narrative

Na.

Event Description

The customer reported that 5 out of 10 cryomacs freezing bags 50 ml exhibited cracking and breaching of integrity upon thawing.The cryomacs freezing bags were used in developmental upstream process, therefore, no patient treatment was affected.The event happened at: (b)(6).

• Brand Name: CRYOMACS FREEZING BAG 50 ML
• Type of Device: CRYOMACS FREEZING BAG 50 ML
• 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; 51429 ; GM 51429
• Manufacturer Contact: nancy johansen ; 85 hamilton st.; cambridge, MA 02139 ; 6172180062
• MDR Report Key: 5018602
• MDR Text Key: 23837914
• Report Number: 3005290010-2015-00008
• Device Sequence Number: 1
• Product Code: KSR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK090020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Report Date: 08/05/2015

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
• Device Operator: Other
• Device Expiration Date: 02/29/2016
• Device Model Number: FREEZING BAG 50 ML
• Device Catalogue Number: 200-074-400
• Device Lot Number: 6130130002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2013
• 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