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)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer complained a broken spike of the drip chamber during insertion of the pall filter the event was detected during set up of the clinimacs tubing set ce.No risk to the patient.

• 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: 5520870
• Report Number: 3005290010-2016-00058
• Device Sequence Number: 18980958
• Product Code: OVG
• UDI-Device Identifier: 04049934004841
• UDI-Public: 4049934004841
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/23/2016

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: 04/13/2018
• Device Catalogue Number: 161-01
• Device Lot Number: B2396
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2016
• Initial Report FDA Received Date: 03/23/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1