MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 160NR DIALYZER FINISHED ASSMBLY; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	0500316N
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
Event or Problem Description
A user facility clinic manager reported an optiflux 160nr dialyzer that was found to have a foreign object inside it.This was discovered prior to use, and there was no patient involvement.The clinic manager advised it appeared the foreign object was additional filter material.The clinic manager confirmed the dialyzer was available to be returned to the plant for investigation.
Additional Manufacturer Narrative
The sample was received.A white dust was present beneath the header cap on the cavity id end of the dialyzer.The characteristics of the dust are consistent with polyurethane cutter dust residue, which may occur during the polyurethane cutting process.There was no other particulate or irregularities noted on the returned dialyzer.A lot history review was performed.There were no other complaints reported against the lot.A review of the production record was performed.There was one approved temporary dn noted on the lot.It is unrelated to the reported complaint event.There was no indication of product non-acceptance or deviation in the manufacturing process potentially related to the complaint.This includes non-conformances, rework, labeling, process controls and any other occurrence in production.The reported lot number passed pyrogen testing, was within sterilization dosage parameters and passed all release criteria.

• Brand Name: OPTIFLUX 160NR DIALYZER FINISHED ASSMBLY
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): OGDEN MANUFACTURING PLANT; 475 west 13th street; ogden UT 84404
• MDR Report Key: 7695465
• Report Number: 1713747-2018-00255
• Device Sequence Number: 16355862
• Product Code: KDI
• UDI-Device Identifier: 00840861100118
• UDI-Public: 00840861100118
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: K002277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2018

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 Catalogue Number: 0500316N
• Device Lot Number: 17PU06022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Device Age: MO
• Initial Date Received by Manufacturer: 07/06/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 07/17/2018
• Supplement Report FDA Received Date: 08/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1