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

Catalog Number	354213
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device involved has been received for evaluation and the investigation is 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: outlook iv set detached from the middle y-site during an infusion.Pump was infusing normal saline solution at a kvo (keep vein open) rate.Nurse walked into patients room and noticed the iv tubing detached at the middle of the y-site.Patient's blood was backing up into the tubing and a puddle of fluid and blood was noted on the floor.Iv infusion was stopped and iv site was capped.No further intervention needed.Customer stated this is the second time the incident happened within a week.No injuries reported.Customer reports 3 potential lot numbers in the facility that could be related to the reported event.Potential lot number: 0061557903, 0061546965, 0061559982.
Additional Manufacturer Narrative
Event 1: this report has been identified as b.Braun medical internal report number (b)(4).One (1) used sample without packaging was returned for evaluation.Upon visual inspection it was noted that the tubing disconnected from the middle caresite.The sample was also cut by the facility proximal to the disconnected caresite.*it should be noted that the original reported item was 375196, but the returned product was 354213.The defect of disconnection at the bonded joint was able to be confirmed through visual inspection.In order to address the issue of disconnection at the bonded joint between the tubing and y-caresite valve b.Braun has initiated a corrective action/preventative action (capa) which provides for root cause analysis and corrective action.Review of the discrepancy management system database performed for the reported lot numbers did not reveal any abnormalities or non-conformance of this nature.We will maintain this report for further references and continue to monitor other reports for similar occurrences.

• 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: 6878943
• Report Number: 9614279-2017-00078
• Device Sequence Number: 659768
• Product Code: FPA
• UDI-Device Identifier: 04046964183034
• UDI-Public: 04046964183034
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 08/23/2017

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: 354213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/23/2017
• Supplement Date Received by Manufacturer: 08/23/2017
• Initial Report FDA Received Date: 09/20/2017
• Supplement Report FDA Received Date: 10/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1