MAUDE Adverse Event Report: MILTENYI BIOTEC GMBH CLINIMACS TUBING SET

Catalog Number	161-01
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/19/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the late reporting by the customer, they could not send ts or photograph of event.
Event or Problem Description
At the time of integrity testing the clinimacs tubing set starting leaking at the clamp site.

• Brand Name: CLINIMACS TUBING SET
• Common Device Name: CLINIMACS TUBING SET
• Manufacturer (Section D): MILTENYI BIOTEC GMBH; friedrich-ebert-strasse 68; bergisch gladbach, 51429 ; GM 51429
• MDR Report Key: 5480718
• Report Number: 3005290010-2016-00053
• Device Sequence Number: 445094
• Product Code: OVG
• UDI-Device Identifier: 04049934004834
• UDI-Public: 04049934004834
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: BH110018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 03/04/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 161-01
• Device Lot Number: B2391
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1