MAUDE Adverse Event Report: MILTENYI BIOTEC GMBH CLINIMACS® PBS/EDTA BUFFER

Model Number N/A

Device Problem Material Rupture (1546)

Patient Problem No Information (3190)

Event Date 07/14/2015

Event Type  malfunction  

Manufacturer Narrative

Device not returned by manufacturer.

Event Description

The customer reported that they found a small, black and rubber-like fragment in one of their clinimacs pbs/edta buffer bags 1l, after spiking.The debris was identified prior to cell processing and therefore the patients cell processing material for transplantation was not affected.The site had a spare buffer on hand that was used for the cell separation process.The cell sample was administered to the patient.Based on the information provided, harm to the patient can be excluded.The event happened at: (b)(6).

• Brand Name: CLINIMACS® PBS/EDTA BUFFER
• Type of Device: CLINIMACS® PBS/EDTA BUFFER
• 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: 5108562
• MDR Text Key: 26940661
• Report Number: 3005290010-2015-00009
• Device Sequence Number: 1
• Product Code: OVG
• UDI-Device Identifier: 04049934001666
• UDI-Public: 04049934001666
• 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: other
• Reporter Occupation: Other
• Remedial Action: Replace
• Report Date: 09/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2017
• Device Model Number: N/A
• Device Catalogue Number: 700-25
• Device Lot Number: D0525
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1