MAUDE Adverse Event Report: MILTENYI BIOTEC GMBH CLINIMACS TUBING SET LS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	05/04/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not returned to the manfuacturer.
Event or Problem Description
The leakage occurred in a clinimacs tubing set ls at the y piece of tubing above the pre-column.This event happened during a validation run.Therefore no patient was affected.

• Brand Name: CLINIMACS TUBING SET LS
• Common Device Name: CLINIMACS TUBING SET LS
• Manufacturer (Section D): MILTENYI BIOTEC GMBH; friedrich-ebert-strasse 68; bergisch gladbach, 51429 ; GM 51429
• MDR Report Key: 5671293
• Report Number: 3005290010-2016-00068
• Device Sequence Number: 73985
• Product Code: OVG
• UDI-Device Identifier: 04049934004841
• UDI-Public: 04049934004841
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: BH110018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/19/2016

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 Model Number: N/A
• Device Catalogue Number: 162-01
• Device Lot Number: NOT KNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2016
• Initial Report FDA Received Date: 05/23/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1