MAUDE Adverse Event Report: B. BRAUN DOMINICAN REPUBLIC INC. OUTLOOK®; SET, ADMINISTRATION, INTRA

Catalog Number	US3120
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).One used sample was returned for evaluation.In an attempt to replicate the reported event, the returned set was attached to an iv bag and once the iv started to flow into the set, the leak was noticed to come from the bonded joint between the upper tubing and the top of the blood filter housing.Although a definitive root cause could not be determined, the most likely root cause is due to insufficient solvent being applied during the manual assembly process.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or lot number.If additional pertinent information becomes available a follow-up report will be filed.
Event or Problem Description
As reported by user facility: leaking of set above the blood filter during blood administration.

• Brand Name: OUTLOOK®
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN DOMINICAN REPUBLIC INC.; las americas industrial park; km22 autopista las americas; santo domingo, dominican republic ; DR
• MDR Report Key: 6109530
• Report Number: 9614279-2016-00098
• Device Sequence Number: 13544005
• Product Code: FPA
• UDI-Device Identifier: 04046964187995
• UDI-Public: (01)04046964187995(17)170630(10)0061381065
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K922637
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 10/22/2014

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: 06/30/2017
• Device Catalogue Number: US3120
• Device Lot Number: 0061381065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2014
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2014
• Initial Report FDA Received Date: 11/17/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1