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

Catalog Number	162-01
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/26/2016
Type of Reportable Event	Malfunction
Event or Problem Description
Clinimacs tubing set ls leaked at the junction between the priming waste bag and tubing.Because this was the second reported case for this lot the customer decided to quarantine the remaining 24 tsls from this lot.The event happened at priming phase therefore material was not affected.The cell separation could be performed with a replacement tubing set.This event occurred at: (b)(6).

• 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: 5469994
• Report Number: 3005290010-2016-00050
• Device Sequence Number: 16244454
• Product Code: OVG
• UDI-Device Identifier: 04049934004841
• UDI-Public: 04049934004841
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Replace
• Type of Report: Initial
• Report Date (Section B): 03/01/2016

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: 05/05/2018
• Device Catalogue Number: 162-01
• Device Lot Number: B2397
• 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: 03/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1