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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Date 09/18/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported there was a leak detected just above the left side of the 3-way junction and below valve 2 after inserting a clinimacs tubing set ls.Since the leak was detected prior to integrity test, no cellular material was affected and therefore no harm caused to the patient.(b)(6).

• Brand Name: CLINIMACS® TUBING SET LS
• Type of Device: CLINIMACS® TUBING SET LS
• Manufacturer (Section D): MILTENYI BIOTEC GMBH; friedrich-ebert-strasse 68; bergisch gladbach, 51429 ; GM 51429
• Manufacturer (Section G): MILTENYI BIOTEC GMBH; friedrich-ebert-strasse 68; bergisch gladbach, 51429 ; GM 51429
• Manufacturer Contact: nancy johansen ; 85 hamilton st; cambridge, MA 02139 ; 6172180062
• MDR Report Key: 5230483
• MDR Text Key: 31409918
• Report Number: 3005290010-2015-00018
• Device Sequence Number: 1
• Product Code: OVG
• UDI-Device Identifier: 04049934004834
• UDI-Public: 04049934004834
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BH110018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2018
• Device Model Number: N/A
• Device Catalogue Number: 162-01
• Device Lot Number: B2393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1