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

Catalog Number	354216
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Although the device involved was confirmed not to be available, the investigation is still ongoing at this time.A follow up will be submitted when the investigation results become available.
Event or Problem Description
As reported by the user facility: customer reports that upon completion of a blood transfusion, blood drops were noted on the outlook infusion pump and on the floor.The clinician then noticed a crack in the tubing.The crack was located near the top clamp of the iv set.It was stated that there was no affect to the patient.
Additional Manufacturer Narrative
(b)(4).As reported by the user facility, the sample was not available for further evaluation.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or non-conformances of this nature.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If a sample and/or any additional pertinent information becomes available, a follow up will be submitted.

• 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, ; DR
• MDR Report Key: 7525262
• Report Number: 9614279-2018-00081
• Device Sequence Number: 11119129
• Product Code: FPA
• UDI-Device Identifier: 04046964182273
• UDI-Public: 04046964182273
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K083723
• 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,Followup
• Report Date (Section B): 06/01/2018

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 Expiration Date: 06/30/2020
• Device Catalogue Number: 354216
• Device Lot Number: 0061572800
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/23/2018
• Supplement Date Received by Manufacturer: 04/23/2018
• Initial Report FDA Received Date: 05/18/2018
• Supplement Report FDA Received Date: 06/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1