FDA Adverse Event Malfunction Summary report: N

CRYOMACS FREEZING BAG 250

MDR report key: 6228881 · Received January 6, 2017

Report

Report Number
3005290010-2016-00102
Event Type
Malfunction
Date Received
January 6, 2017
Date of Event
November 30, 2016
Report Date
January 5, 2017
Manufacturer
MILTENYI BIOTEC GMBH
Product Code
LPZ
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
UK
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

A CAP OF CRYOMACS FREEZING BAG 250 SEEMED CROSS-THREADED AND WAS FOUND DURING THE PRE-PROCESS CHECK. NO PATIENT AFFECTED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
12103 CRYOMACS FREEZING BAG 250 CRYOMACS FREEZING BAG 250 LPZ MILTENYI BIOTEC GMBH N/A 6151202002

Patients

Seq Age Sex Outcome Treatment
1