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
This report has been identified as b.Braun inc.Internal report # (b)(4).One used set was received for evaluation.The set was tested for leakage per the specification, and there was leakage observed from the top cap of the blood filter housing.As this is a purchased part from filtertek, the sample and all available information regarding this complaint was sent to the supplier for evaluation: scan number (b)(4).In order to help mitigate the potential root causes, filtertek, the supplier modified the solvent drying carrousel control to eliminate occurrences of units with shorter drying times after assembly of the filter, and a poke-yoke, go/no-go gage was implemented to mitigate in-process issues regarding the tubing close to or out of spec at the higher tolerance.The supplier also performed an adjustment of the carousel fixture to also help prevent parts from being bent or over-pressed if the tubing is close to the upper spec.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature.If additional pertinent information becomes available a follow-up report will be filed.This case is being filed retrospectively as a result of a review of recent customer complaint information.Based on additional information and details provided in another complaint case, it was determined that this case is reportable in accordance with the requirements of 21 cfr 803.B.Braun has conducted a retrospective review for all complaints of a similar nature in accordance with internal procedure (b)(4).
Event or Problem Description
As reported by user facility: filter chamber cracked, leaking saline and blood.

• 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: 6133531
• Report Number: 9614279-2016-00129
• Device Sequence Number: 16259442
• Product Code: FPA
• UDI-Device Identifier: 04046964187995
• UDI-Public: (01)04046964187995(17)180531(10)0061438546
• 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): 08/21/2015

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: 05/31/2018
• Device Catalogue Number: US3120
• Device Lot Number: 0061438546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2015
• Initial Report FDA Received Date: 11/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1